Class II Furcation DefectNCT07776756
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
A study testing Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative and Periodontal Regenerative Surgery With Xenograft and Collagen Membrane in people with Class II Furcation Defect, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Class II Furcation Defect
- What is being tested?
- Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative and Periodontal Regenerative Surgery With Xenograft and Collagen Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteVietnam
- Study dates
- 29 Jun 2026to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Full-mouth plaque score (FMPS) ≤ 20%.
- Full-mouth bleeding score (FMBS) ≤ 20%.
- Willingness to participate in the study and provide informed consent.
- Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2.
- Probing pocket depth (PPD) ≥ 5 mm at the eligible furcation site.
- Keratinized gingival height ≥ 2 mm at the eligible site.
- No gingival recession extending apically beyond the buccal furcation roof; the furcation entrance must not be clinically exposed above the gingival margin.
Who cannot join
- Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency.
- Pregnancy or breastfeeding.
- Untreated endodontic pathology involving the study tooth.
- Class III furcation involvement according to the Hamp classification.
- Untreated occlusal trauma involving the study tooth.
- Grade II tooth mobility that has not been stabilized by splinting, or Grade III tooth mobility according to the Miller classification.
- Defective restorations at the surgical site, including overhanging, bulky, or poorly adapted restorations.
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
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Binh Phu, 700000
Tuong Vy T Huynh, +84 765 414 119, htrtuongvy@gmail.com
About this study
Official title: Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars
This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration.
Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery.
The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.
Read the detailed description
This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.
Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).
Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.
Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.
At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.
The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.
- Conditions
- Class II Furcation Defect
- Being tested
- Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative, Periodontal Regenerative Surgery With Xenograft and Collagen Membrane
- Keywords
- Periodontal Regeneration, Enamel Matrix Derivative, Xenograft, Emdogain, Collagen Membrane, Class II Furcation, Mandibular Molar, Cerabone, Bio-Gide, TWEAK, TNF-like weak inducer of apoptosis (TWEAK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Regenerative Surgery With Xenograft and Enamel Matrix DerivativeProcedure or surgery
Periodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD). After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect. The xenograft bone is mixed with EMD and placed to completely fill the defect. The flap is then repositioned and sutured.
Periodontal Regenerative Surgery With Xenograft and Collagen MembraneProcedure or surgery
Periodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane. After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect. A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft + Enamel Matrix Derivative | Experimental | Not described Receives: Procedure: Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative |
| Xenograft + Collagen Membrane | Active comparator | Not described Receives: Procedure: Periodontal Regenerative Surgery With Xenograft and Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth. Measurements are standardized using an individualized acrylic stent. The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
Measured: Baseline and 6 months after surgery
Change in Horizontal Clinical Attachment Loss (HCAL)
Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
Measured: Baseline and 6 months after surgery
Secondary outcomes (11)
Change in Vertical Clinical Attachment Loss (VCAL)
Measured: Baseline and 6 months after surgery
Change in Buccal Gingival Recession (REC)
Measured: Baseline, 3 months, and 6 months after surgery
Change in Plaque Index (PI)
Measured: Baseline, 3 months, and 6 months after surgery
Change in Gingival Index (GI)
Measured: Baseline and 6 months after surgery
Change in Furcation Defect Volume on CBCT
Measured: Baseline and 6 months after surgery
Change in Relative Bone Density on CBCT
Measured: Baseline and 6 months after surgery
Change in Gingival Crevicular Fluid TWEAK Concentration
Measured: Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Measured: 12 hours, 24 hours, and 72 hours after surgery
Postoperative Analgesic Consumption
Measured: During the first 3 days after surgery
Patient Satisfaction With Postoperative Swelling
Patient-reported satisfaction with postoperative swelling will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
Measured: 3 and 7 days after surgery
Patient Satisfaction With Chewing Ability
Patient-reported satisfaction with chewing ability after surgery will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
Measured: 3 and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start29 Jun 2026
- Primary completion29 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Furcation 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vy Truong Tuong Huynh, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776756
- Sponsor's protocol ID
- 26412-ĐHYD
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars
- ClinicalTrials.gov ID
- NCT07776756
- Acronym / sponsor ID
- 26412-ĐHYD
- Conditions
- Class II Furcation Defect
- Keywords
- Periodontal Regeneration, Enamel Matrix Derivative, Xenograft, Emdogain, Collagen Membrane, Class II Furcation, Mandibular Molar, Cerabone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Aug 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 randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration.
Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery.
The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.
Detailed description
This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.
Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).
Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.
Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.
At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.
The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenograft + Enamel Matrix Derivative | Experimental | Procedure: Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative |
| Xenograft + Collagen Membrane | Active comparator | Procedure: Periodontal Regenerative Surgery With Xenograft and Collagen Membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older.
- Full-mouth plaque score (FMPS) ≤ 20%.
- Full-mouth bleeding score (FMBS) ≤ 20%.
- Willingness to participate in the study and provide informed consent.
- Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2.
Key exclusion criteria (7 listed)
- Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency.
- Pregnancy or breastfeeding.
- Untreated endodontic pathology involving the study tooth.
- Class III furcation involvement according to the Hamp classification.
- Untreated occlusal trauma involving the study tooth.
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 |
|---|---|---|
| Periodontal Regenerative Surgery With Xenograft and Enamel Matrix DerivativePeriodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD). After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect. The xenograft bone is mixed with EMD and placed to completely fill the defect. The flap is then repositioned and sutured. | Procedure or surgery | Xenograft + Enamel Matrix Derivative |
| Periodontal Regenerative Surgery With Xenograft and Collagen MembranePeriodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane. After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect. A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing. | Procedure or surgery | Xenograft + Collagen Membrane |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 6 months after surgery
Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth. Measurements are standardized using an individualized acrylic stent. The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
Change in Horizontal Clinical Attachment Loss (HCAL)
Time frame: Baseline and 6 months after surgery
Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
11 secondary outcomes
Change in Vertical Clinical Attachment Loss (VCAL)
Time frame: Baseline and 6 months after surgery
Change in Buccal Gingival Recession (REC)
Time frame: Baseline, 3 months, and 6 months after surgery
Change in Plaque Index (PI)
Time frame: Baseline, 3 months, and 6 months after surgery
Change in Gingival Index (GI)
Time frame: Baseline and 6 months after surgery
Change in Furcation Defect Volume on CBCT
Time frame: Baseline and 6 months after surgery
Change in Relative Bone Density on CBCT
Time frame: Baseline and 6 months after surgery
Change in Gingival Crevicular Fluid TWEAK Concentration
Time frame: Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Time frame: 12 hours, 24 hours, and 72 hours after surgery
Postoperative Analgesic Consumption
Time frame: During the first 3 days after surgery
Patient Satisfaction With Postoperative Swelling
Time frame: 3 and 7 days after surgery
Patient Satisfaction With Chewing Ability
Time frame: 3 and 7 days 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 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Class II Furcation Defect
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Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
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.
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative and Periodontal Regenerative Surgery With Xenograft and Collagen Membrane in people with Class II Furcation 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 8 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline and 6 months after surgery). 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 20 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.