Extraction Socket HealingPhase 4NCT07270510
The Effect of Collagen In Tooth Extraction Procedures
A Phase 4 study testing Collagen Matrix soft tissue graft in people with Extraction Socket Healing and Extraction, Tooth, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Extraction Socket Healing, Extraction, Tooth
- What is being tested?
- Collagen Matrix soft tissue graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 20 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Collagen Matrix soft tissue graft
- Keywords
- collagen matrix, alveolar socket preservation, alveolar ridge, bone resorption, socket seal
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Matrix soft tissue graftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Collagen Matrix soft tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal Height (BH)
Measurement of Buccal Height using CBCT scans
Measured: From intervention day to 3 months follow-up
Buccal Width (BW)
Buccal Width measurements using CBCT scans
Measured: From intervention day to 3-month follow-up
Secondary outcomes (4)
Palatal/lingual Height (PH)
Palatal/lingual height measuerements using CBCT scans
Measured: From intervention day to 3-month follow-up
Palatal/lingual Width (PW)
Palatal/lingual width measurements using CBCT scans
Measured: From intervention day to 3-month follow-up
Gingival Thickness (GT)
Gingival Thickness measurement using periodontal probe
Measured: From intervention day to 3-month follow-up
Keratinized Tissue Width (KTW)
Keratinized Tissue Width measured using periodontal probe
Measured: From intervention day to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction Socket HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a parallel arm randomized clinical trial consisting of a control and a test group with same number of participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulhuseyn Abdullayev, Altinbas University
- Investigators
- Sebnem Dirikan Ipci, Prof., Study director, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270510
- Sponsor's protocol ID
- 2025/136 REV2
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing may be available upon rasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Volumetric Evaluation of Collagen Matrix Efficacy in Alveolar Socket Preservation, Randomized Clincal Trial
- ClinicalTrials.gov ID
- NCT07270510
- Acronym / sponsor ID
- 2025/136 REV2
- Conditions
- Extraction Socket Healing, Extraction, Tooth
- Keywords
- collagen matrix, alveolar socket preservation, alveolar ridge, bone resorption, socket seal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel arm randomized clinical trial consisting of a control and a test group with same number of participants.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Collagen Matrix soft tissue graftThe test group received Collagen Matrix onto their extraction sockets after extractions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%
Key exclusion criteria (1 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen Matrix soft tissue graftCircular 8 mm diameter collagen matrix grafts were sutured to seal extraction sockets in the participants. The sutures were removed 1 week after the intervention. | Device | Test Group |
Primary outcome
Buccal Height (BH)
Time frame: From intervention day to 3 months follow-up
Measurement of Buccal Height using CBCT scans
Buccal Width (BW)
Time frame: From intervention day to 3-month follow-up
Buccal Width measurements using CBCT scans
4 secondary outcomes
Palatal/lingual Height (PH)
Time frame: From intervention day to 3-month follow-up
Palatal/lingual Width (PW)
Time frame: From intervention day to 3-month follow-up
Gingival Thickness (GT)
Time frame: From intervention day to 3-month follow-up
Keratinized Tissue Width (KTW)
Time frame: From intervention day to 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided. IPD sharing may be available upon rasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebnem Dirikan Ipci, Prof. study director
Altinbas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagen Matrix soft tissue graft in people with Extraction Socket Healing and Extraction, Tooth, run by Altinbas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal Height (BH) (time frame: From intervention day to 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.