Treatment of Intraosseous Periodontal Defects With Amelogenins

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Periodontal Bone Loss, Periodontal Pocket

Intervention / Treatment
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* Other: MINSD and amelogenins
* Other: MINSD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amelogenin Group (A)<br>Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) | Other: MINSD and amelogenins<br>* 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.<br>|
| Active Comparator: No-amelogenin Group (B)<br>Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed | Other: MINSD<br>* Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Clinical Attachment Level (CAL) gain (millimeters) | Distance from the cementoenamel junction to the bottom of the pocket | baseline and 6 months after periodontal therapy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Therapy, Periodontal Bone Loss, Amelogenin, Intraosseous Bone Defect