Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT01431131
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.

Condition or Disease	Intervention/Treatment	Phase
Clinical Efficacy	Procedure: Intrasocket graft; Procedure: Intrasocket plus facial overlay graft	N/A

Detailed Description

Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intrasocket graft Positive control	Procedure: Intrasocket graft; Intrasocket mineralized cancellous allograft
Experimental: Intrasocket plus facial overlay graft Intrasocket cancellous allograft plus a facial overlay bovine xenograft	Procedure: Intrasocket plus facial overlay graft; Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft

Outcome Measures

Primary Outcome Measures

1. Horizontal Ridge Dimension [Baseline and 4 months]

   WIll be measured with a digital caliper at baseline and 4 months.

Secondary Outcome Measures

1. Histologic Healing of the Osseous Graft [4 months]

   Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.

2. Healthy person that is at least 18 years old.

3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.

2. Molar teeth.

3. Presence of or history of osteonecrosis of the jaws.

4. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.

5. Patients who have been treated with oral bisphosphonates for more than three years.

6. Pregnant women due to the possibility of miscarriage.

7. Patients with an allergy to any material or medication used in the study.

8. Patients who need prophylactic antibiotics.

9. Previous head and neck radiation therapy.

10. Chemotherapy in the previous 12 months.

11. Patients on long term NSAID or steroid therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Graduate Periodontics Clinic, School of Dentistry, University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

• Principal Investigator: Henry Greenwell, DMD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT01431131
• Other Study ID Numbers: 11.0352
• First Posted: Sep 9, 2011
• Last Update Posted: Jan 31, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Henry Greenwell, Principal Investigator, University of Louisville: graft placement; bone resorption

Study Results

Participant Flow

Recruitment Details	The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.

Arm/Group Title	Intrasocket Graft	Intrasocket Plus Facial Overlay Graft
Arm/Group Description	Positive control, an intrasocket cancellous allograft is placed	Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intrasocket Graft	Intrasocket Plus Facial Overlay Graft	Total
Arm/Group Description	Positive control, an intrasocket cancellous allograft was placed	Intrasocket cancellous allograft plus a facial overlay bovine xenograft	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 83.3%	10 83.3%	20 83.3%
>=65 years	2 16.7%	2 16.7%	4 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (16)	58 (11)	55 (14)
Gender (Count of Participants)
Female	8 66.7%	5 41.7%	13 54.2%
Male	4 33.3%	7 58.3%	11 45.8%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Horizontal Ridge Dimension
Description	WIll be measured with a digital caliper at baseline and 4 months.
Time Frame	Baseline and 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intrasocket Graft	Intrasocket Plus Facial Overlay Graft
Arm/Group Description	Positive control, an intrasocket cancellous allograft was placed	Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Measure Participants	12	11
Mean (Standard Deviation) [mm]	-1.6 (0.8)	-0.3 (0.9)

2. Secondary Outcome

Title	Histologic Healing of the Osseous Graft
Description	Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intrasocket Graft	Intrasocket Plus Facial Overlay Graft
Arm/Group Description	Positive control, an intrasocket cancellous allograft was placed	Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Measure Participants	12	11
Mean (Standard Deviation) [percentage vital bone]	35 (16)	40 (16)

Adverse Events

Time Frame	From the beginning to the end of the study.
Arm/Group Title	Intrasocket Graft		Intrasocket Plus Facial Overlay Graft
Arm/Group Description	Positive control, an intrasocket cancellous allograft will be placed		Intrasocket cancellous allograft plus a facial overlay bovine xenograft
All Cause Mortality
	Intrasocket Graft		Intrasocket Plus Facial Overlay Graft
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intrasocket Graft		Intrasocket Plus Facial Overlay Graft
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Intrasocket Graft		Intrasocket Plus Facial Overlay Graft
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

There were no adverse events. 1 patient in the Intrasocket plus facial overlay graft group was excluded as an outlier. There was a large amount of bone gain and this skewed the data.

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.