Wisdom ToothPhase 4PCL ECMNCT07834645
Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.
A Phase 4 study testing polycarprolactone membrane (PCL membrane) and Extracellular matrix collagen (ECM) membrane in people with Wisdom Tooth and Socket Preservation, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Wisdom Tooth, Socket Preservation
- What is being tested?
- polycarprolactone membrane (PCL membrane) and Extracellular matrix collagen (ECM) membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 May 2025to 30 Sep 2027
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient who requires surgical removal of bilateral impacted M3.
- Patient with impacted bilateral M3 which are sound.
- Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification.
- Presence of disease-free mandibular second molar (M2) adjacent to the M3 to be extracted
- Patient aged 18 to 35 years old who are medically fit
Who cannot join
- Impacted M3 associated with:
- Fracture of angle of mandible.
- Radiological evidence of cyst or tumour.
- Incomplete root formation.
- Acute pulpitis or severe pericoronitis that is not under controlled.
- Gross dental caries.
Show all 14Show fewer
- Retained roots of mandibular third molar with history of removal or coronectomy of unerupted/impacted M3.
- Patients with periodontal disease
- Patients with absence of lower second molars.
- Medically compromised patients
- Pregnant women.
- Patient on oral contraceptives.
- Current or previous bisphosphonate therapy or history of radiotherapy to the jaws.
- Active smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.
This study compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving PCL membrane and the other receiving ECM membrane after socket filled with EthOss (an alloplastic bone graft). Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays.
Read the detailed description
Surgical removal of impacted mandibular third molars (M3) often associated with post-operative morbidities such as pain, facial swelling, limited mouth opening and injuries to the inferior alveolar nerve or lingual nerve. In addition, it can result in compromised periodontal health of the adjacent second molar (M2) and reduced alveolar bone height at the M3 region. The defect can be restored using bone substitutes with membrane. This study aims to assess wound healing of the surgical sites of third molar surgery with application of alloplastic bone graft with PCL membrane and ECM-collagen membrane. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket covered with PCL membrane and ECM-collagen membrane after filled up EthOss® alloplastic graft. The participants will be reviewed at post-operative 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) to monitor for signs of graft reaction/rejection. Periodontal assessments were performed at these four visits to assess the soft tissue healing. Radiological assessment (intraoral periapical x-ray) will be done at preoperative and post-operative week 24 to assess bone depth.
- Conditions
- Wisdom Tooth, Socket Preservation
- Being tested
- polycarprolactone membrane (PCL membrane), Extracellular matrix collagen (ECM) membrane
- Keywords
- PCL membrane, ECM membrane, socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polycarprolactone membrane (PCL membrane)Combination product
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast.
Extracellular matrix collagen (ECM) membraneCombination product
Also called ECM membrane
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast.
| Study group | Role | What they receive |
|---|---|---|
| PCL membrane | Active comparator | This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar Receives: Combination Product: Extracellular matrix collagen (ECM) membrane |
| ECM collagen membrane | Active comparator | This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar Receives: Combination Product: polycarprolactone membrane (PCL membrane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal health assessment on lower second molar (1)
- Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health.
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal health assessment on lower second molar (2)
Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal health assessment on lower second molar (3)
Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while >5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health.
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal health assessment on lower second molar (4)
Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal health assessment on lower second molar (5)
The healing index of Landry (Grade 1 poor to Grade 5 excellent)
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Secondary outcomes (2)
The width of keratinized tissue
The width of the keratinized gingiva will also be measured buccolingual at 6mm distal to the M2.
Measured: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Bone gain at distal of lower second molar
The radiographic bone level will be measured at T0 and T4 as the distance between the distal point of a line passing through the cemento-enamel junction of M2 (mesial and distal projection of M2's CEJ) and the bone peak distal to M2, at the bottom of the bony defect Measurement in milimeter.
Measured: radiograph taken prior to surgery and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start2 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wisdom ToothStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Single group
- Model description
- This is a split mouth study, within a single patient with PCL membrane and ECM collagen membrane placed on each side of lower wisdom tooth socket after filled with allograft (Ethoss).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopore International
- Responsible party
- Principal investigator, Tan Chuey Chuan, University of Malaya
- Investigators
- Wei Cheong Ngeow, PhD, Study director, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, MalaysiaRou Enn Ng, BDS, Principal investigator, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834645
- Sponsor's protocol ID
- DF OS 2512/0060 (P)
- Other IDs
- UMG057E-2025
- Acronym
- PCL ECM
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.
Publications
Aimetti, M., Romano, F., Pigella, E., Pranzini, F., & Debernaerdi, C. (2005). Treatment of Wide, Shallow, and Predominantly 1-Wall Intrabony Defects With a Bioabsorbable Membrane: A Randomized Controlled Clinical Trial. Journal of Periodontology, 76(8), 1354-1361. Bohner, M., Santoni, B. L. G., & Dobelin, N. (2020). Beta-tricalcium phosphate for bone substitution: Synthesis and properties. Acta Biomater, 113, 23-41. Canullo, L., Rossi-Fedele, G., Camodeca, F., Menini, M., & Pesce, P. (2021). A Pilot Retrospective Study on the Effect of Bone Grafting after Wisdom Teeth Extraction. Materials (Basel), 14(11https://doi.org/10.3390/ma14112844). Chen, G., Sato, T., Ohgushi, H., Ushida, T., Tateishi, T., & Tanaka, J. (2005). Culturing of skin fibroblasts in a thin PLGA-collagen hybrid mesh. Biomaterials, 26(15), 2559-2566. De Angelis, N., Pesce, P., Poedjiastoeti, W., Suwandi, T., Tjandrawinata, R., Bagnasco, F., & Menini, M. (2024). 3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study. Dent J (Basel), 12(10). Retrieved Oct 7, from https://www.ncbi.nlm.nih.gov/pubmed/39452449 Dodson, T. B. (2004). Management of Mandibular Third Molar Extraction Sites to Prevent Periodontal Defects. Journal of Oral and Maxillofacial Surgery, 62(10), 1213-1224. Fairbairn, P., Kilner, S., O'Hooley, D., Fish, A., & Kurtzman, G. M. (2023). Sinus Augmentation for Implant Placement Utilizing a Novel Synthetic Graft Material with Delayed Immediate Socket Grafting: A 2-Year Case Study. J. Clin. Med, 12(1). Goh, B. T., Teh, L. Y., Tan, D. B., Zhang, Z., & Teoh, S. H. (2015). Novel 3D polycaprolactone scaffold for ridge preservation--a pilot randomised controlled clinical trial. Clin Oral Implants Res, 26(3), 271-277. Retrieved Mar, from https://www.ncbi.nlm.nih.gov/pubmed/25263527 Jambhekar, S., Kernen, F., & Bidra, A. S. (2015). Clinical and histologic outcomes of socket grafting after flapless tooth extraction:
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.
- ClinicalTrials.gov ID
- NCT07834645
- Acronym / sponsor ID
- PCL ECM / DF OS 2512/0060 (P)
- Conditions
- Wisdom Tooth, Socket Preservation
- Keywords
- PCL membrane, ECM membrane, socket preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Osteopore International
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Sep 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 compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving PCL membrane and the other receiving ECM membrane after socket filled with EthOss (an alloplastic bone graft). Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays.
Detailed description
Surgical removal of impacted mandibular third molars (M3) often associated with post-operative morbidities such as pain, facial swelling, limited mouth opening and injuries to the inferior alveolar nerve or lingual nerve. In addition, it can result in compromised periodontal health of the adjacent second molar (M2) and reduced alveolar bone height at the M3 region. The defect can be restored using bone substitutes with membrane. This study aims to assess wound healing of the surgical sites of third molar surgery with application of alloplastic bone graft with PCL membrane and ECM-collagen membrane. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket covered with PCL membrane and ECM-collagen membrane after filled up EthOss® alloplastic graft. The participants will be reviewed at post-operative 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) to monitor for signs of graft reaction/rejection. Periodontal assessments were performed at these four visits to assess the soft tissue healing. Radiological assessment (intraoral periapical x-ray) will be done at preoperative and post-operative week 24 to assess bone depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a split mouth study, within a single patient with PCL membrane and ECM collagen membrane placed on each side of lower wisdom tooth socket after filled with allograft (Ethoss).
| Arm | Type | Receives |
|---|---|---|
| PCL membrane | Active comparator | Combination Product: Extracellular matrix collagen (ECM) membraneThis is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar |
| ECM collagen membrane | Active comparator | Combination Product: polycarprolactone membrane (PCL membrane)This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient who requires surgical removal of bilateral impacted M3.
Key exclusion criteria (14 listed)
- Impacted M3 associated with:
- Retained roots of mandibular third molar with history of removal or coronectomy of unerupted/impacted M3.
- Patients with periodontal disease
- Patients with absence of lower second molars.
- Medically compromised patients
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 |
|---|---|---|
| polycarprolactone membrane (PCL membrane)This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast. | Combination product | ECM collagen membrane |
| Extracellular matrix collagen (ECM) membraneAlso: ECM membraneThis is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast. | Combination product | PCL membrane |
Primary outcome
Periodontal health assessment on lower second molar (1)
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
1. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health.
Periodontal health assessment on lower second molar (2)
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health
Periodontal health assessment on lower second molar (3)
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while >5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health.
Periodontal health assessment on lower second molar (4)
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.
Periodontal health assessment on lower second molar (5)
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
The healing index of Landry (Grade 1 poor to Grade 5 excellent)
2 secondary outcomes
The width of keratinized tissue
Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Bone gain at distal of lower second molar
Time frame: radiograph taken prior to surgery and 24 weeks after surgery
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 22 Sep 2026.
- BackgroundAimetti, M., Romano, F., Pigella, E., Pranzini, F., & Debernaerdi, C. (2005). Treatment of Wide, Shallow, and Predominantly 1-Wall Intrabony Defects With a Bioabsorbable Membrane: A Randomized Controlled Clinical Trial. Journal of Periodontology, 76(8), 1354-1361. Bohner, M., Santoni, B. L. G., & Dobelin, N. (2020). Beta-tricalcium phosphate for bone substitution: Synthesis and properties. Acta Biomater, 113, 23-41. Canullo, L., Rossi-Fedele, G., Camodeca, F., Menini, M., & Pesce, P. (2021). A Pilot Retrospective Study on the Effect of Bone Grafting after Wisdom Teeth Extraction. Materials (Basel), 14(11https://doi.org/10.3390/ma14112844). Chen, G., Sato, T., Ohgushi, H., Ushida, T., Tateishi, T., & Tanaka, J. (2005). Culturing of skin fibroblasts in a thin PLGA-collagen hybrid mesh. Biomaterials, 26(15), 2559-2566. De Angelis, N., Pesce, P., Poedjiastoeti, W., Suwandi, T., Tjandrawinata, R., Bagnasco, F., & Menini, M. (2024). 3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study. Dent J (Basel), 12(10). Retrieved Oct 7, from https://www.ncbi.nlm.nih.gov/pubmed/39452449 Dodson, T. B. (2004). Management of Mandibular Third Molar Extraction Sites to Prevent Periodontal Defects. Journal of Oral and Maxillofacial Surgery, 62(10), 1213-1224. Fairbairn, P., Kilner, S., O'Hooley, D., Fish, A., & Kurtzman, G. M. (2023). Sinus Augmentation for Implant Placement Utilizing a Novel Synthetic Graft Material with Delayed Immediate Socket Grafting: A 2-Year Case Study. J. Clin. Med, 12(1). Goh, B. T., Teh, L. Y., Tan, D. B., Zhang, Z., & Teoh, S. H. (2015). Novel 3D polycaprolactone scaffold for ridge preservation--a pilot randomised controlled clinical trial. Clin Oral Implants Res, 26(3), 271-277. Retrieved Mar, from https://www.ncbi.nlm.nih.gov/pubmed/25263527 Jambhekar, S., Kernen, F., & Bidra, A. S. (2015). Clinical and histologic outcomes of socket grafting after flapless tooth extraction:
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.
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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.
Wei Cheong Ngeow, PhD study director
Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
Rou Enn Ng, BDS principal investigator
Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
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 polycarprolactone membrane (PCL membrane) and Extracellular matrix collagen (ECM) membrane in people with Wisdom Tooth and Socket Preservation, run by University of Malaya at 1 site in Malaysia.
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 5 inclusion and 14 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 22 Sep 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 Malaysia. 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?
Periodontal health assessment on lower second molar (1) (time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery). The study lists 5 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 NCT07834645, which also lists 1 linked publication.
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 22 Sep 2026.