Periodontal DefectNCT07114523
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
A study testing collagen membrane and third molar surgery in people with Periodontal Defect, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Periodontal Defect
- What is being tested?
- collagen membrane and third molar surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2024to 31 Mar 2027
- Phase
- Interventional
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 25 years or older.
- Patients with mesioangular or horizontally impacted mandibular third molars. The highest point of mandibular third molars are lower than the occlusal surface of adjacent second molars (classified B, C according to Pell - Gregory's category).
- Patients with symmetrical lower third molars on both sides with same classification according to Pell - Gregory's category. The difference of third molars inclination on both side is not more than 15°.
- Patients with lower second molars on both sides have no cavities or fillings that affect the determination of the cemento-enamel junction.
- Patients are explained, counseled clearly and sign their consent to participate in the study.
Who cannot join
- Patients with coagulation or immune disorders.
- Patients allergic to local anesthetics (Lidocaine 2% with Adrenaline 1:100,000) or any drugs used in the study.
- Patients allergic to products or food derived from pigs.
- Pregnant or breastfeeding patients.
- Patients who smoke.
- Patients with systemic conditions that contraindicate surgical procedures.
- Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or in proximity to the mandibular third molar.
- Patients with missing mandibular second molars.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City
Phong Cu Lam, MD.DDS, +84932114888, lamcuphong@ump.edu.vn
About this study
Official title: Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. A typical scenario involves a mesioangularly impacted third molar exerting pressure on the distal alveolar bone of the second molar, resulting in persistent food impaction that is difficult for patients to clean. Furthermore, the surgical removal of deeply impacted or severely angulated mandibular third molars often requires bone removal in the area adjacent to the second molar. These factors may exacerbate distal periodontal defects of the second molar, especially in individuals over the age of 25. This research focuses on evaluating the effectiveness of a new-generation collagen membrane in promoting healing after the extraction of impacted mandibular third molars in patients at risk of distal periodontal tissue damage to the second molars
- Conditions
- Periodontal Defect
- Being tested
- collagen membrane, third molar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen membraneProcedure or surgery
collagen membrane apply to distal surface of second molar after third molar surgery
third molar surgeryProcedure or surgery
standard third molar surgery without any additional application
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | apply collagen membrane on distal surface of second molar after third molar surgery Receives: Procedure: collagen membrane |
| control | Active comparator | standard third molar surgery without any application Receives: Procedure: third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal periodontal tissue status
distal periodontal tissue status was assessed using variables of pocket depth
Measured: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)
Secondary outcomes (1)
Distal bone level
The variable was determined by measuring the distance from the CEJ of mandibular second molar to the highest point of the alveolar crest, performed with the periapical radiograph using the parallel technique, standardized with a film holder and a stent with a 5 mm steel segment
Measured: at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DefectStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This type of interventional study in dentistry is referred to as a split-mouth design. In this design, the intervention subjects have bilaterally symmetrical conditions within the oral cavity, allowing one side to serve as the intervention group while the contralateral side serves as the control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Cu Phong, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114523
- Sponsor's protocol ID
- 3566/DHYD-HDDD
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07114523
- Acronym / sponsor ID
- 3566/DHYD-HDDD
- Conditions
- Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Aug 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.
Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. A typical scenario involves a mesioangularly impacted third molar exerting pressure on the distal alveolar bone of the second molar, resulting in persistent food impaction that is difficult for patients to clean. Furthermore, the surgical removal of deeply impacted or severely angulated mandibular third molars often requires bone removal in the area adjacent to the second molar. These factors may exacerbate distal periodontal defects of the second molar, especially in individuals over the age of 25. This research focuses on evaluating the effectiveness of a new-generation collagen membrane in promoting healing after the extraction of impacted mandibular third molars in patients at risk of distal periodontal tissue damage to the second molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This type of interventional study in dentistry is referred to as a split-mouth design. In this design, the intervention subjects have bilaterally symmetrical conditions within the oral cavity, allowing one side to serve as the intervention group while the contralateral side serves as the control group.
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Procedure: collagen membraneapply collagen membrane on distal surface of second molar after third molar surgery |
| control | Active comparator | Procedure: third molar surgerystandard third molar surgery without any application |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 25 years or older.
- Patients with mesioangular or horizontally impacted mandibular third molars. The highest point of mandibular third molars are lower than the occlusal surface of adjacent second molars (classified B, C according to Pell - Gregory's category).
- Patients with symmetrical lower third molars on both sides with same classification according to Pell - Gregory's category. The difference of third molars inclination on both side is not more than 15°.
- Patients with lower second molars on both sides have no cavities or fillings that affect the determination of the cemento-enamel junction.
- Patients are explained, counseled clearly and sign their consent to participate in the study.
Key exclusion criteria (8 listed)
- Patients with coagulation or immune disorders.
- Patients allergic to local anesthetics (Lidocaine 2% with Adrenaline 1:100,000) or any drugs used in the study.
- Patients allergic to products or food derived from pigs.
- Pregnant or breastfeeding patients.
- Patients who smoke.
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 membranecollagen membrane apply to distal surface of second molar after third molar surgery | Procedure or surgery | study |
| third molar surgerystandard third molar surgery without any additional application | Procedure or surgery | control |
Primary outcome
Distal periodontal tissue status
Time frame: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)
distal periodontal tissue status was assessed using variables of pocket depth
1 secondary outcome
Distal bone level
Time frame: at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen membrane and third molar surgery in people with Periodontal Defect, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 8 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 Vietnam. 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?
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?
Contact Phong Cu Lam, MD.DDS (+84932114888, lamcuphong@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal periodontal tissue status (time frame: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)). 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 29 Oct 2026.