Treatment of Intraosseous Periodontal Defects With Amelogenins

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05315804

Collaborator

(none)

Enrollment

Location

Arms

10.1

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.

A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).

Condition or Disease	Intervention/Treatment	Phase
Periodontal Bone Loss Periodontal Pocket	Other: MINSD and amelogenins Other: MINSD	N/A

Detailed Description

The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.

Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).

Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).

After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.

In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.

Masking:

Single (Participant)

Masking Description:

Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization

Primary Purpose:

Treatment

Official Title:

Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amelogenin Group (A) Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)	Other: MINSD and amelogenins After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
Active Comparator: No-amelogenin Group (B) Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed	Other: MINSD Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Arm

Intervention/Treatment

Experimental: Amelogenin Group (A)

Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)

Other: MINSD and amelogenins

After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.

Active Comparator: No-amelogenin Group (B)

Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed

Other: MINSD

Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Outcome Measures

Primary Outcome Measures

Change of Clinical Attachment Level (CAL) gain (millimeters) [baseline and 6 months after periodontal therapy]
Distance from the cementoenamel junction to the bottom of the pocket

Secondary Outcome Measures

Change of Probing Depth (PD) (millimeters) [baseline and 6 months after periodontal therapy]
Distance from the gingival margin to the bottom of the pocket
Change of Gingival Recession (GR) (millimeters) [baseline and 6 months after periodontal therapy]
Distance from gingival margin to the cementoenamel junction
Change of Radiographic Defect Angle (RDA) (grade °) [baseline and 6 months after periodontal therapy]
Radiographic intraosseous angle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients diagnosed with periodontitis;
Age ≥ 18 years old;
Presence of at least 10 teeth per arch;
Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
Presence of at least one intraosseous pocket;
Single-rooted and multi-rooted teeth.

Exclusion Criteria:

Patients with systemic diseases;
Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
Pregnant or lactating;
Tobacco smokers (≥ 10 cigarettes per day);
Multi-rooted teeth with furcation involvement;
Third molars.