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

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Procedure: alveolar ridge preservation

• Registration Number: NCT05188196
• Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-12
• Study Start: 2022-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age ≥ 18 years
2. Need for molar extraction due to periodontal disease and plan for late implantation
3. No acute infection, such as abscess or effusion
4. 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
5. Presence of one adjacent tooth to the extraction site

Exclusion Criteria

1. Smoking
2. Pregnancy or lactation
3. Untreated periodontal disease
4. Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
5. Under radiotherapy
6. Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
7. Extraction of multiple adjacent teeth
8. Allergy to any of the materials used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Sponge	alveolar ridge preservation	ridge preservation with collagen sponge + collagenated bovine bone mineral
Collagen Membrane	alveolar ridge preservation	ridge preservation with collagen membrane + collagenated bovine bone mineral

Primary Outcome Measures

Name	Time	Method
change from baseline vertical height of ridge at 6 months	baseline, at 6 months	vertical height of ridge at the buccal and palatal/lingual plates
change from baseline horizontal width of ridge at 6 months	baseline, at 6 months	horizontal width of ridge at 1, 3, 5mm below crest

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China