The Effect of Collagen In Tooth Extraction Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-02-20

Brief Summary

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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.

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Detailed Description

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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

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Extraction Socket Healing Extraction, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a parallel arm randomized clinical trial consisting of a control and a test group with same number of participants.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor was blinded to minimize data analysis bias..

Study Groups

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Control Group

The control group only went through routine tooth extractions without further interventions. Extraction sockets were left to spontaneous healing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Test Group

The test group received Collagen Matrix onto their extraction sockets after extractions.

Group Type ACTIVE_COMPARATOR

Collagen Matrix soft tissue graft

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes