The Effect of Collagen In Tooth Extraction Procedures

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extraction Socket Healing; Extraction, Tooth
• Intervention / Treatment: Device: Collagen Matrix soft tissue 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34147
      • Altinbas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatal/lingual Height (PH)	Palatal/lingual height measuerements using CBCT scans	From intervention day to 3-month follow-up
Palatal/lingual Width (PW)	Palatal/lingual width measurements using CBCT scans	From intervention day to 3-month follow-up
Gingival Thickness (GT)	Gingival Thickness measurement using periodontal probe	From intervention day to 3-month follow-up
Keratinized Tissue Width (KTW)	Keratinized Tissue Width measured using periodontal probe	From intervention day to 3-month follow-up

Collaborators and Investigators

• Sponsor: Altinbas University
• Investigators: Study Director: Sebnem Dirikan Ipci, Prof., Altinbas University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: collagen matrix; alveolar ridge; bone resorption; socket seal; alveolar socket preservation
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Bone Resorption
• Other Study ID Numbers: 2025/136 REV2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing may be available upon rasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No