Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.

Detailed Description
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The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.

Official Title
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Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: alveolar ridge preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Need for molar extraction due to periodontal disease and plan for late implantation No acute infection, such as abscess or effusion Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm Presence of one adjacent tooth to the extraction site Exclusion Criteria: Smoking Pregnancy or lactation Untreated periodontal disease Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.) Under radiotherapy Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.) Extraction of multiple adjacent teeth Allergy to any of the materials used in the study

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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No

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagen Membrane<br>ridge preservation with collagen membrane + collagenated bovine bone mineral | Procedure: alveolar ridge preservation<br>* Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.<br>|
| Experimental: Collagen Sponge<br>ridge preservation with collagen sponge + collagenated bovine bone mineral | Procedure: alveolar ridge preservation<br>* Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline horizontal width of ridge at 6 months | horizontal width of ridge at 1, 3, 5mm below crest | baseline, at 6 months | 
| change from baseline vertical height of ridge at 6 months | vertical height of ridge at the buccal and palatal/lingual plates | baseline, at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| width of keratinized tissue | measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe | at 6 months | 
| thickness of mucosa | measured at the mid-buccal aspect using an endodontic file with a rubber stop | at 6 months | 
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at 2 weeks |