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The Effect of Collagen In Tooth Extraction Procedures

A

Altinbas University

Status and phase

Active, not recruiting
Phase 4

Conditions

Extraction Socket Healing
Extraction, Tooth

Treatments

Device: Collagen Matrix soft tissue graft

Study type

Interventional

Funder types

Other

Identifiers

NCT07270510
2025/136 REV2

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adults (absence of cardiovascular diseases, thyroid diseases, oncological diseases Non-smokers Extraction diagnosis on non-molar teeth Gingivitis, stage 1-2 periodontitis conditions Absence of radiotherapy last 2 years Non restorable teeth (deep fracture, excessive caries, failed root canal treatment) Overall plaque score and gingival score of <10%

Exclusion criteria

Systemically compromised patients Smokers Pregnancy or lactation Heavy periodontally compromised patients (Stage 3-4) Patients undergone radiotherapy in the last 2 years Collagen allergic patients Restorable teeth Overall plaque score and gingival score of >10%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Control Group
No Intervention group
Description:
The control group only went through routine tooth extractions without further interventions. Extraction sockets were left to spontaneous healing.
Test Group
Active Comparator group
Description:
The test group received Collagen Matrix onto their extraction sockets after extractions.
Treatment:
Device: Collagen Matrix soft tissue graft

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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