Comparing collagen sponge and membrane for preserving tooth sockets in gum disease patients
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
This study is testing whether a collagen sponge or a collagen membrane helps people with gum disease keep their jawbone shape after having their molars removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05188196 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different materials, collagen sponge and collagen membrane, used alongside collagenated bovine bone mineral for preserving the ridge of the jawbone after the extraction of periodontally compromised molars. Patients will be randomly assigned to receive either the collagen sponge or collagen membrane treatment, and their clinical and radiographic outcomes will be assessed before surgery and six months postoperatively. Key measurements will include changes in ridge width, height, keratinized tissue, and mucosal thickness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require molar extraction due to periodontal disease and plan for future dental implants.
Not a fit: Patients with untreated periodontal disease, severe systemic conditions, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing tooth extraction due to periodontal disease by enhancing ridge preservation and facilitating future dental implants.
How similar studies have performed: Other studies have shown promising results with similar approaches in ridge preservation, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Peihui Ding, Doctor — The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
- Study coordinator: Weida Li, master
- Email: kyb@zjkq.com.cn
- Phone: 0571-87219287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.