Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

• Sponsor: Institut Straumann AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01614925
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Attachment Loss; Periodontal Diseases	Device: Emdogain; Procedure: Periodontal surgery

Detailed Description

The following secondary endpoints will be evaluated during the study:

• Change in Gingival Margin (GM) at 12 months after surgery compared to baseline

• Change in Probing Pocket Depth (PPD) at 12 months after surgery compared to baseline

• Comparison of early wound healing index (EHI) at 4 weeks after surgery between treatment groups

• Comparison of post-surgical pain at 4 weeks after surgery between treatment groups

• Change in Bleeding on Probing (BoP) at 12 months after surgery compared to baseline

• Change in root dentin hypersensitivity at 12 months after surgery compared to baseline

• Change in full mouth plaque index (PI) at 12 months after surgery compared to baseline

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emdogain Periodontal surgery with the additional use of Straumann® Emdogain	Device: Emdogain; Periodontal surgery with the additional use of Straumann® Emdogain
Active Comparator: Periodontal Surgery Periodontal surgery alone	Procedure: Periodontal surgery; Periodontal surgery alone

Outcome Measures

Primary Outcome Measures

1. Clinical Attachment Level [12 Months]

   The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.

Secondary Outcome Measures

1. Change in Gingival Margin (GM) From Baseline to 12 Months [12 months after baseline]

   GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ.

2. Change in Probing Pocket Depth (PPD) From Baseline to 12 Months [12 months after baseline]

   PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth.

3. Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline [4 weeks after baseline]

   Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment: complete flap closure - no fibrin line in the interproximal area complete flap closure - fine fibrin line in the interproximal area complete flap closure - fibrin clot in the interproximal area incomplete flap closure - partial necrosis of the interproximal tissue incomplete flap closure - complete necrosis of the interproximal tissue The outcome measure was the percentage of EHI category 1 (complete flap closure - no fibrin line in the interproximal area)

4. Comparison of Post-surgical Pain at 4 Weeks After Baseline [4 weeks after baseline]

   Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome

5. Change in Bleeding on Probing (BoP) From Baseline to 12 Months [12 months after baseline]

   The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP.

6. Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months [12 months after baseline]

   RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH.

7. Change in Plaque Index (PI) From Baseline to 12 Months [12 months after baseline]

   The PI was recorded according to O'Leary et al. [1972] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have advanced periodontitis:

• presence of supra-alveolar-type defects (i.e., defects displaying a predominantly horizontal pattern of bone loss) at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth (FDI positions 17-27 or 37-47) in either the maxilla or the mandible with a PPD of ≥6 mm at a minimum on one site of the examined teeth

• Teeth must have < Class II mobility

• Teeth must have horizontal bone loss with an intrabony component of <2 mm as defined by radiographic evaluation

• Subjects must have adequate oral hygiene (full mouth plaque index (PI) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)

• Subjects must have adequate control of inflammation (full mouth bleeding on probing (FMBP) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)

• Subjects must have voluntarily signed the informed consent form before any study related procedures

• Subjects must be males and females of at least 18 years of age

• Subjects must be committed to the study and the required follow-up visits

• Subjects must be in good general health as assessed by the investigator at time of surgery

Exclusion Criteria:

Pre-surgical exclusion criteria:

• Subjects with any contraindications for oral surgical procedures

• Subjects with uncontrolled diabetes or other uncontrolled systemic diseases

• Subjects with disorders or treatments that compromise wound healing

• Subjects with medical conditions requiring chronic high dose steroid therapy

• Subjects with bone metabolic diseases

• Subjects with radiation or other immuno-oppressive therapy

• Subjects with infections or vascular impairment at the surgical site

• Subjects who are on antibiotic treatment or chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to surgery.

• Subjects with the presence of oral lesions (such as ulceration, malignancy)

• Subjects with mucosal diseases (e.g., lichen planus, mouth ulcer)

• Subjects with a history of malignant disease in the oral cavity or previous radiotherapy to the head or neck

• Subjects with inadequate oral hygiene or unmotivated for adequate home care

• Subjects that have been treated with an investigational drug or device within the 30 day period immediately prior to surgery on study day 0.

• Subjects who currently smoke

• Female subjects who are nursing, pregnant, or plan to become pregnant

Secondary exclusion criteria:

• Subjects with an osseous defect with an intrabony component of ≥2 mm or involving furcation involvement ≥ class II at the tooth of interest

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• Institut Straumann AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Straumann AG
• ClinicalTrials.gov Identifier: NCT01614925
• Other Study ID Numbers: CR 02/11
• First Posted: Jun 8, 2012
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Periodontal Diseases; Periodontal Attachment Loss

Study Results

Participant Flow

Recruitment Details	The recruitment was terminated prematurely.

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Period Title: Overall Study
STARTED	18	17
COMPLETED	14	15
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Emdogain	Periodontal Surgery	Total
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone	Total of all reporting groups
Overall Participants	18	17	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (14.0)	53.9 (13.2)	52.4 (13.2)
Sex: Female, Male (Count of Participants)
Female	8 44.4%	14 82.4%	22 62.9%
Male	10 55.6%	3 17.6%	13 37.1%
Region of Enrollment (participants) [Number]
United States	5 27.8%	7 41.2%	12 34.3%
Switzerland	3 16.7%	3 17.6%	6 17.1%
Germany	10 55.6%	7 41.2%	17 48.6%

Outcome Measures

1. Primary Outcome

Title	Clinical Attachment Level
Description	The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Mean (Standard Deviation) [mm]	-2.91 (1.3)	-2.08 (1.32)

2. Secondary Outcome

Title	Change in Gingival Margin (GM) From Baseline to 12 Months
Description	GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ.
Time Frame	12 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Mean (Standard Deviation) [mm]	-0.36 (0.84)	-0.27 (1.53)

3. Secondary Outcome

Title	Change in Probing Pocket Depth (PPD) From Baseline to 12 Months
Description	PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth.
Time Frame	12 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Mean (Standard Deviation) [mm]	-2.93 (1.44)	-2.47 (1.12)

4. Secondary Outcome

Title	Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline
Description	Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment: complete flap closure - no fibrin line in the interproximal area complete flap closure - fine fibrin line in the interproximal area complete flap closure - fibrin clot in the interproximal area incomplete flap closure - partial necrosis of the interproximal tissue incomplete flap closure - complete necrosis of the interproximal tissue The outcome measure was the percentage of EHI category 1 (complete flap closure - no fibrin line in the interproximal area)
Time Frame	4 weeks after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Number [percentage of EHI category 1]	93	100

5. Secondary Outcome

Title	Comparison of Post-surgical Pain at 4 Weeks After Baseline
Description	Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome
Time Frame	4 weeks after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Mean (Standard Deviation) [score on a scale]	3.21 (9.39)	3.47 (7.77)

6. Secondary Outcome

Title	Change in Bleeding on Probing (BoP) From Baseline to 12 Months
Description	The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP.
Time Frame	12 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Number [percentage of BoP change]	-36	-13

7. Secondary Outcome

Title	Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months
Description	RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH.
Time Frame	12 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Number [percentage of RDH change]	-21.4	-26.7

8. Secondary Outcome

Title	Change in Plaque Index (PI) From Baseline to 12 Months
Description	The PI was recorded according to O'Leary et al. [1972] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI.
Time Frame	12 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emdogain	Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Measure Participants	14	15
Number [percentage of PI change]	14.7	13.4

Adverse Events

Time Frame	1 year
Arm/Group Title	Emdogain		Periodontal Surgery
Arm/Group Description	Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain		Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
All Cause Mortality
	Emdogain		Periodontal Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Emdogain		Periodontal Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Emdogain		Periodontal Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		1/17 (5.9%)
General disorders
Tooth hypersensitivity	0/18 (0%)	0	1/17 (5.9%)	1
Aphthous ulcer	1/18 (5.6%)	1	0/17 (0%)	0

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed. This sponsor decision was based on commercial reasons and not linked to any safety concerns or new scientific knowledge.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.