The Effect of Collagen In Tooth Extraction Procedures

NCT07270510 | Active Not Recruiting Phase 4

• 1 other identifier: 2025/136 REV2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extraction Socket Healing; Extraction, Tooth

Keywords

collagen matrix; alveolar socket preservation; alveolar ridge; bone resorption; socket seal

Outcome Measures

Primary Outcomes (2)

• Buccal Height (BH)

  Measurement of Buccal Height using CBCT scans

  From intervention day to 3 months follow-up

• Buccal Width (BW)

  Buccal Width measurements using CBCT scans

  From intervention day to 3-month follow-up

Secondary Outcomes (4)

• Palatal/lingual Height (PH)

  From intervention day to 3-month follow-up

• Palatal/lingual Width (PW)

  From intervention day to 3-month follow-up

• Gingival Thickness (GT)

  From intervention day to 3-month follow-up

• Keratinized Tissue Width (KTW)

  From intervention day to 3-month follow-up

Study Arms (2)

Control Group

NO INTERVENTION

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

Test Group

ACTIVE COMPARATOR

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

Device: Collagen Matrix soft tissue graft

Interventions

Collagen Matrix soft tissue graft 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.

Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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%

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University

Istanbul, Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Sebnem Dirikan Ipci, Prof.

  Altinbas University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was blinded to minimize data analysis bias..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 20, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

TU (1)