Using a collagen matrix to prevent bone loss during dental implant placement in the front teeth area.
The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall During Implant Placement in the Aesthetic Zone. A Randomized Controlled Clinical Trial.
This study is testing whether a special collagen matrix can help prevent bone loss better than traditional tissue grafts during dental implant placement in the front teeth area for healthy adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Thessaloniki, Thessaloniki) |
| Trial ID | NCT06622759 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a porcine collagen matrix versus traditional autogenous connective tissue grafts in preventing buccal bone resorption during single dental implant placement in the aesthetic zone. The study will involve 36 generally healthy adult participants who require an implant in the upper aesthetic zone and will assess clinical and radiographic outcomes six months post-operation. The trial is designed as a prospective, randomized controlled study, focusing on both histological assessments and patient-reported outcomes to evaluate the success of the interventions.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 18 or older who need a single implant in the upper aesthetic zone with specific ridge width and gingiva requirements.
Not a fit: Patients with poor oral hygiene, heavy smoking habits, or those requiring bone augmentation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive alternative for soft tissue augmentation, improving aesthetic outcomes for patients receiving dental implants.
How similar studies have performed: While the use of collagen matrices in dental procedures is being explored, this specific comparative approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Generally healthy adult patients. 2. 18 years or older. 3. Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar) 4. Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point. 5. Minimum 2mm of attached gingiva. 6. Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations. 7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form Exclusion Criteria: 1. Poor oral hygiene (FMPS \< 20%, FMBS \< 15%) and poor motivation 2. Heavy smokers (\>10 cigarettes per day) 3. Need for bone augmentation 4. Untreated periodontitis 5. General contraindications for dental and/or surgical treatment 6. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years 7. Women of child bearing age, not using a standard accepted method for contraception 8. Pregnancy or breast feeding 9. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs 10. Disease affecting connective tissue metabolism (e.g. collagenases) 11. Allergy to collagen
Where this trial is running
Thessaloniki, Thessaloniki
- Department of Preventive Dentistry, Periodontology & Implant Biology, School of Dentistry, Aristotle University — Thessaloniki, Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Ioannis Vouros, DDS, Ph.D
- Email: iovouros@dent.auth.gr
- Phone: +302310999597
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.