Impacted Mandibular Third MolarPRFvsCOLL-3MNCT07530068
Adjacent Molar Outcomes After Third Molar Surgery With PRF or Collagen Sponge
A study testing Platelet-rich fibrin (PRF) and Absorbable Collagen Sponge in people with Impacted Mandibular Third Molar and Wound Healing, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare platelet-rich fibrin (PRF) and an absorbable collagen sponge in extraction sockets following impacted mandibular third molar removal in terms of postoperative clinical healing and periodontal and radiographic outcomes of adjacent second molars. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar, Wound Healing, Postoperative Pain
- What is being tested?
- Platelet-rich fibrin (PRF) and Absorbable Collagen Sponge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of bilaterally impacted mandibular third molars
- Indication for extraction due to recurrent pericoronitis, non-restorable caries, or periodontal or orthodontic reasons
- Age between 18 and 30 years
- Systemically healthy individuals
Who cannot join
- Presence of acute infection or pathology in the surgical region
- Systemic or immunological disease
- Uncontrolled diabetes mellitus
- History of chemotherapy or radiotherapy
- Use of anticoagulants, steroids, or medications affecting bone metabolism
- Pregnancy
- Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
Ankara, Ankara, 06490
About this study
Official title: Adjacent Molar Outcomes After Impacted Mandibular Third Molar Surgery With PRF or Collagen Sponge: A Randomized Split-Mouth Trial
This study aims to compare platelet-rich fibrin (PRF) and an absorbable collagen sponge in extraction sockets following impacted mandibular third molar removal in terms of postoperative clinical healing and periodontal and radiographic outcomes of adjacent second molars.
Twenty-nine systemically healthy patients with bilaterally symmetrical impacted mandibular third molars will be included, and a total of 58 extraction sockets will be analyzed. Patients will be randomized using a sealed-envelope method into either the PRF group or the absorbable collagen sponge (Surgispon) group. In this split-mouth design, one side will receive the intervention and the contralateral side will serve as a control.
Clinical and periodontal parameters will be recorded postoperatively, and radiographic healing will be evaluated using fractal analysis and lacunarity.
Read the detailed description
This study is designed as a prospective, randomized, controlled, split-mouth clinical trial to evaluate the effects of platelet-rich fibrin (PRF) and an absorbable collagen sponge on postoperative healing following impacted mandibular third molar extraction.
Impacted mandibular third molar surgery is commonly associated with postoperative complications such as pain, swelling, trismus, and delayed healing. In addition, periodontal defects on the distal surface of the adjacent second molar and delayed bone healing in the extraction socket are clinically important concerns.
PRF is an autologous biomaterial rich in growth factors that may support tissue healing and regeneration. Absorbable collagen sponges are biocompatible materials that stabilize the blood clot and provide a scaffold for tissue regeneration. However, direct comparisons of these two materials within the same patient population are limited.
A total of 29 systemically healthy patients aged between 18 and 30 years with bilaterally symmetrical impacted mandibular third molars will be included. A split-mouth design will be used, where one side will receive the intervention and the contralateral side will serve as a control. Randomization will be performed using a sealed-envelope method.
All surgical procedures will be performed under local anesthesia using a standardized protocol. Following tooth extraction, PRF or collagen sponge will be applied to the socket according to randomization, while the control side will heal naturally. All surgical sites will be sutured using a standardized technique.
Postoperative care will be standardized for all patients. Clinical evaluation will include postoperative pain, swelling, and the presence of alveolar osteitis. Periodontal evaluation will include probing depth, gingival recession, gingival index, and bleeding on probing at the distal aspect of the second molar.
Radiographic evaluation will be performed using standardized periapical radiographs. Fractal analysis and lacunarity measurements will be used to assess trabecular bone structure and healing.
Statistical analysis will be conducted using appropriate parametric or non-parametric tests based on data distribution, with a significance level set at p < 0.05.
- Being tested
- Platelet-rich fibrin (PRF), Absorbable Collagen Sponge
- Keywords
- Platelet-Rich Fibrin (PRF), Absorbable Collagen Sponge, Mandibular Third Molar Surgery, Split-Mouth Design, Postoperative Pain, Wound Healing, Alveolar Bone Healing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Platelet-rich fibrin (PRF) is prepared from autologous venous blood by centrifugation without the use of anticoagulants. The obtained fibrin clot is placed into the extraction socket immediately after mandibular third molar removal to promote wound healing and reduce postoperative complications.
Absorbable Collagen SpongeBiological
Also called spongostan, surgispon
An absorbable collagen sponge is placed into the extraction socket immediately after mandibular third molar removal. The material is used to support hemostasis and promote wound healing. No additional biomaterials are applied.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Fibrin (PRF) | Experimental | n this split-mouth design, platelet-rich fibrin (PRF) is applied to the extraction socket of the impacted mandibular third molar on the allocated side following tooth removal. The contralateral side serves as an untreated control. Receives: Biological: Platelet-rich fibrin (PRF) |
| Control (PRF group) | No intervention | In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided |
| Collagen Sponge (Surgispon) | Experimental | In this split-mouth design, an absorbable collagen sponge (Spongostan) is placed into the extraction socket on the allocated side following mandibular third molar removal. The contralateral side serves as an untreated control. Receives: Biological: Absorbable Collagen Sponge |
| Control (Spongostan group) | No intervention | In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractal Dimension and Lacunarity Values for Bone Healing
Radiographic bone healing in the extraction socket will be evaluated using fractal analysis and lacunarity measurements derived from standardized radiographs.
Measured: 12 weeks postoperatively
Postoperative Pain Score (Visual Analog Scale)
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain.
Measured: 3 days postoperatively
Secondary outcomes (6)
Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm)
Postoperative facial swelling will be assessed by measuring the distance (in millimeters) between the tragus and oral commissure, and between the tragus and pogonion using a standardized measuring tape.
Measured: posoperatively 3 days
Number of Participants with Alveolar Osteitis (Clinical Diagnosis)
Alveolar osteitis will be diagnosed clinically based on the presence of postoperative pain and exposed bone in the extraction socket.
Measured: post op 7 days
Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar
Periodontal probing depth (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.
Measured: post op 7 days
Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar
Gingival recession (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.
Measured: post op 7 days
Gingival Index Score (Löe and Silness Index, 0-3 Scale)
Gingival inflammation will be assessed using the Löe and Silness Gingival Index (0-3 scale), where higher scores indicate greater inflammation.
Measured: post op 7 days
Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar)
Bleeding on probing will be assessed at the distal aspect of the mandibular second molar and recorded as present or absent.
Measured: postop 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start28 Feb 2025
- Primary completion30 Nov 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third MolarStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized split-mouth clinical trial includes two parallel split-mouth cohorts. In one cohort, participants with bilaterally impacted mandibular third molars are randomly assigned to receive platelet-rich fibrin (PRF) on one side, while the contralateral side serves as an untreated control. In the second cohort, participants are randomly assigned to receive an absorbable collagen sponge (Spongostan) on one side, while the contralateral side serves as an untreated control. Thus, each participant serves as their own control. Clinical and radiographic outcomes are evaluated at predefined postoperative time points.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur MOLLAOGLU, Gazi University
- Investigators
- Nur Mollaoglu, OMFS PROFESSOR, Principal investigator, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, TurkeyAhmet Talha OSMANOĞLU, OMFS RESİDENT, Study director, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530068
- Sponsor's protocol ID
- M3-405030
- Acronym
- PRFvsCOLL-3M
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JW, Seong TW, Cho S, Kim SJ. Randomized controlled trial on the effectiveness of absorbable collagen sponge after extraction of impacted mandibular third molar: split-mouth design. BMC Oral Health. 2020 Mar 18;20(1):77. doi: 10.1186/s12903-020-1063-3.
PubMed 32183831Zwittnig K, Kirnbauer B, Truschnegg A, Jakse N, Wolf A, Sokolowski A, Mischak I, Payer M. Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study. Clin Oral Investig. 2024 Oct 29;28(11):615. doi: 10.1007/s00784-024-06002-9.
PubMed 39467892Mettes TD, Ghaeminia H, Nienhuijs ME, Perry J, van der Sanden WJ, Plasschaert A. Surgical removal versus retention for the management of asymptomatic impacted wisdom teeth. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD003879. doi: 10.1002/14651858.CD003879.pub3.
PubMed 22696337Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o.
PubMed 8233418Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.
PubMed 15510357
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjacent Molar Outcomes After Impacted Mandibular Third Molar Surgery With PRF or Collagen Sponge: A Randomized Split-Mouth Trial
- ClinicalTrials.gov ID
- NCT07530068
- Acronym / sponsor ID
- PRFvsCOLL-3M / M3-405030
- Keywords
- Platelet-Rich Fibrin (PRF), Absorbable Collagen Sponge, Mandibular Third Molar Surgery, Split-Mouth Design, Postoperative Pain, Wound Healing, Alveolar Bone Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Apr 2026 (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 aims to compare platelet-rich fibrin (PRF) and an absorbable collagen sponge in extraction sockets following impacted mandibular third molar removal in terms of postoperative clinical healing and periodontal and radiographic outcomes of adjacent second molars.
Twenty-nine systemically healthy patients with bilaterally symmetrical impacted mandibular third molars will be included, and a total of 58 extraction sockets will be analyzed. Patients will be randomized using a sealed-envelope method into either the PRF group or the absorbable collagen sponge (Surgispon) group. In this split-mouth design, one side will receive the intervention and the contralateral side will serve as a control.
Clinical and periodontal parameters will be recorded postoperatively, and radiographic healing will be evaluated using fractal analysis and lacunarity.
Detailed description
This study is designed as a prospective, randomized, controlled, split-mouth clinical trial to evaluate the effects of platelet-rich fibrin (PRF) and an absorbable collagen sponge on postoperative healing following impacted mandibular third molar extraction.
Impacted mandibular third molar surgery is commonly associated with postoperative complications such as pain, swelling, trismus, and delayed healing. In addition, periodontal defects on the distal surface of the adjacent second molar and delayed bone healing in the extraction socket are clinically important concerns.
PRF is an autologous biomaterial rich in growth factors that may support tissue healing and regeneration. Absorbable collagen sponges are biocompatible materials that stabilize the blood clot and provide a scaffold for tissue regeneration. However, direct comparisons of these two materials within the same patient population are limited.
A total of 29 systemically healthy patients aged between 18 and 30 years with bilaterally symmetrical impacted mandibular third molars will be included. A split-mouth design will be used, where one side will receive the intervention and the contralateral side will serve as a control. Randomization will be performed using a sealed-envelope method.
All surgical procedures will be performed under local anesthesia using a standardized protocol. Following tooth extraction, PRF or collagen sponge will be applied to the socket according to randomization, while the control side will heal naturally. All surgical sites will be sutured using a standardized technique.
Postoperative care will be standardized for all patients. Clinical evaluation will include postoperative pain, swelling, and the presence of alveolar osteitis. Periodontal evaluation will include probing depth, gingival recession, gingival index, and bleeding on probing at the distal aspect of the second molar.
Radiographic evaluation will be performed using standardized periapical radiographs. Fractal analysis and lacunarity measurements will be used to assess trabecular bone structure and healing.
Statistical analysis will be conducted using appropriate parametric or non-parametric tests based on data distribution, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This randomized split-mouth clinical trial includes two parallel split-mouth cohorts. In one cohort, participants with bilaterally impacted mandibular third molars are randomly assigned to receive platelet-rich fibrin (PRF) on one side, while the contralateral side serves as an untreated control. In the second cohort, participants are randomly assigned to receive an absorbable collagen sponge (Spongostan) on one side, while the contralateral side serves as an untreated control. Thus, each participant serves as their own control. Clinical and radiographic outcomes are evaluated at predefined postoperative time points.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Fibrin (PRF) | Experimental | Biological: Platelet-rich fibrin (PRF)n this split-mouth design, platelet-rich fibrin (PRF) is applied to the extraction socket of the impacted mandibular third molar on the allocated side following tooth removal. The contralateral side serves as an untreated control. |
| Control (PRF group) | No intervention | –In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided |
| Collagen Sponge (Surgispon) | Experimental | Biological: Absorbable Collagen SpongeIn this split-mouth design, an absorbable collagen sponge (Spongostan) is placed into the extraction socket on the allocated side following mandibular third molar removal. The contralateral side serves as an untreated control. |
| Control (Spongostan group) | No intervention | –In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of bilaterally impacted mandibular third molars
- Indication for extraction due to recurrent pericoronitis, non-restorable caries, or periodontal or orthodontic reasons
- Age between 18 and 30 years
- Systemically healthy individuals
Key exclusion criteria (7 listed)
- Presence of acute infection or pathology in the surgical region
- Systemic or immunological disease
- Uncontrolled diabetes mellitus
- History of chemotherapy or radiotherapy
- Use of anticoagulants, steroids, or medications affecting bone metabolism
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Platelet-rich fibrin (PRF) is prepared from autologous venous blood by centrifugation without the use of anticoagulants. The obtained fibrin clot is placed into the extraction socket immediately after mandibular third molar removal to promote wound healing and reduce postoperative complications. | Biological | Platelet-Rich Fibrin (PRF) |
| Absorbable Collagen SpongeAlso: spongostan, surgisponAn absorbable collagen sponge is placed into the extraction socket immediately after mandibular third molar removal. The material is used to support hemostasis and promote wound healing. No additional biomaterials are applied. | Biological | Collagen Sponge (Surgispon) |
Primary outcome
Fractal Dimension and Lacunarity Values for Bone Healing
Time frame: 12 weeks postoperatively
Radiographic bone healing in the extraction socket will be evaluated using fractal analysis and lacunarity measurements derived from standardized radiographs.
Postoperative Pain Score (Visual Analog Scale)
Time frame: 3 days postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain.
6 secondary outcomes
Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm)
Time frame: posoperatively 3 days
Number of Participants with Alveolar Osteitis (Clinical Diagnosis)
Time frame: post op 7 days
Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar
Time frame: post op 7 days
Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar
Time frame: post op 7 days
Gingival Index Score (Löe and Silness Index, 0-3 Scale)
Time frame: post op 7 days
Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar)
Time frame: postop 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 32183831Kim JW, Seong TW, Cho S, Kim SJ. Randomized controlled trial on the effectiveness of absorbable collagen sponge after extraction of impacted mandibular third molar: split-mouth design. BMC Oral Health. 2020 Mar 18;20(1):77. doi: 10.1186/s12903-020-1063-3.
- Results publication: PubMed 39467892Zwittnig K, Kirnbauer B, Truschnegg A, Jakse N, Wolf A, Sokolowski A, Mischak I, Payer M. Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study. Clin Oral Investig. 2024 Oct 29;28(11):615. doi: 10.1007/s00784-024-06002-9.
- Results publication: PubMed 22696337Mettes TD, Ghaeminia H, Nienhuijs ME, Perry J, van der Sanden WJ, Plasschaert A. Surgical removal versus retention for the management of asymptomatic impacted wisdom teeth. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD003879. doi: 10.1002/14651858.CD003879.pub3.
- Results publication: PubMed 8233418Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o.
- Results publication: PubMed 15510357Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.
- Randomized controlled split-mouth trial on the effectiveness of platelet-rich fibrin after impacted mandibular third molar extraction.Link provided by the sponsor.
- Randomized controlled split-mouth trial evaluating the effectiveness of absorbable collagen sponge after impacted mandibular third molar extraction.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nur Mollaoglu, OMFS PROFESSOR principal investigator
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
Ahmet Talha OSMANOĞLU, OMFS RESİDENT study director
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin (PRF) and Absorbable Collagen Sponge in people with Impacted Mandibular Third Molar and Wound Healing, run by Gazi 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 15 Apr 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fractal Dimension and Lacunarity Values for Bone Healing (time frame: 12 weeks postoperatively). 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?
On the ClinicalTrials.gov record for NCT07530068, which also lists 5 linked publications.
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 15 Apr 2026.