NCT07270510

The Effect of Collagen In Tooth Extraction Procedures

Clinical and Volumetric Evaluation of Collagen Matrix Efficacy in Alveolar Socket Preservation, Randomized Clincal Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Altinbas University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is aimed at assessing the effect of an animal-derived collagen matrix on bone and soft tissues in the human teeth. Single-rooted teeth that are beyond restoration and in need of extraction will be included in the study. Patients will be divided into two comparable groups in a randomized manner. The first group will proceed with tooth extraction only, which will be left for spontaneous healing. The second (test) group will receive an additional collagen matrix graft after the extraction, which will be sutured to the tooth socket. Sutures will be removed 1 week after surgery. Both groups will undergo CBCT imaging on the day of surgery and at the 3-month follow-up. Differences in bone measurements like height and width will be recorded as well as soft tissue measurements like thickness and width. Data acquired from two groups will be compared against each other to specify the protective effect of the applied collagen matrix graft.

Detailed description

To assess the clinical and volumetric efficacy of the porcine-derived collagen matrix during alveolar socket preservation is aimed in this study that is a randomized controlled clinical trial including two study groups. 24 participants with extraction indication in their non-molar teeth that are eligible will be recruited to the study according to the inclusion criteria of the trial. After the initial oral assessment, the participants were allocated into one of the groups via online randomizer software. Both groups will have the teeth extracted in an atraumatic way using dental periotomes to reduce the surgical trauma and unfavorable healing pattern. Control group sockets will heal spontaneously without any additional procedures. Test group sockets will be applied 8 mm circular collagen matrix grafts with 5/0 propylene sutures to secure the grafts in the sockets. The sutures will be removed at the 1-week follow-up. Both groups will be prescribed analgesic drugs and antimicrobial oral rinse. CBCT imaging will be performed right after surgery and at the 3-month follow-up. Volumetric measurements, like bone heights and widths, will be recorded in this period. Soft tissue changes will be recorded by oral examinations. Inter-group and intra-group differences will be assessed statistically.

Conditions

• Extraction Socket Healing
• Extraction, Tooth

Interventions

Type	Name	Description
DEVICE	Collagen Matrix soft tissue graft	Circular 8 mm diameter collagen matrix grafts were sutured to seal extraction sockets in the participants. The sutures were removed 1 week after the intervention.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-02-20
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Turkey (Türkiye)