PeriodontitisNCT07770256
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
A study testing Acellular Dermal Matrix + EMD + Xenograft and Autogenous Connective Tissue Graft + EMD + Xenograft in people with Periodontitis and Periodontitis (Stage 3), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study consists of two components evaluating furcation involvement in mandibular molars among Stage III or Stage IV periodontitis patients. Component 1 is a cross-sectional study evaluating the prevalence and morphological characteristics of Hamp Class II furcation defects during initial screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontitis (Stage 3), Furcation Defects
- What is being tested?
- Acellular Dermal Matrix + EMD + Xenograft and Autogenous Connective Tissue Graft + EMD + Xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteVietnam
- Study dates
- 2 May 2026to May 2028
- 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
- Patients aged 18 years or older who signed the informed consent form.
- Diagnosed with Stage III or Stage IV periodontitis according to the 2017 AAP/EFP classification.
- Completed non-surgical periodontal therapy with full-mouth plaque score (FMPS) and bleeding on probing (FMBS) <= 20%.
- Presence of at least one mandibular molar with Hamp Class II furcation involvement (horizontal bone loss > 3 mm without through-and-through communication).
- Target tooth requirements:
- Probing pocket depth (PPD) >= 5 mm.
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- Clinical attachment loss (CAL) >= 3 mm.
- Tooth mobility <= Grade I (Miller index).
- Vital pulp or adequately filled root canal treatment without periapical radiolucency.
- Gingival margin positioned coronal to the furcation entrance.
- Intact tooth structure without root fractures or furcation caries.
Who cannot join
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes, hypertension, cardiovascular disease, severe osteoporosis).
- Pregnant or lactating women.
- Current smokers or individuals who quit smoking less than 6 months prior to enrollment.
- Use of antibiotics, anti-inflammatory agents, or medications affecting bone metabolism (e.g., bisphosphonates, high-dose corticosteroids, anti-resorptive drugs) within the past 3 months.
- Previous periodontal surgery at the evaluation site within the past 6 months.
- Target teeth presenting with:
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- Miller Grade II or Grade III tooth mobility.
- Severe bone destruction extending to the root apex.
- Metallic restorations (metal crowns, amalgam fillings, or large metallic posts) causing significant scatter/artifacts on CBCT scans.
- Fused roots or abnormal root anatomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nga Tran Yen, PhD, DDS contact
Vietnam1 site, 1 recruiting
- Recruiting
Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
Dental University of Medicine and Pharmacy, +84 028 3855 8735, khoarhm@ump.edu.vn
Nguyen Trung Hung, MSc, DDS
About this study
Official title: Morphological Characteristics of Furcation Involvement in Mandibular Molars and Efficacy of Regenerative Surgical Treatment: A Cross-Sectional and Interventional Trial
This study consists of two components evaluating furcation involvement in mandibular molars among Stage III or Stage IV periodontitis patients. Component 1 is a cross-sectional study evaluating the prevalence and morphological characteristics of Hamp Class II furcation defects during initial screening. Component 2 is a randomized controlled clinical trial in 30 selected patients comparing the diagnostic accuracy of Cone Beam Computed Tomography (CBCT) against direct intra-operative clinical measurements, as well as evaluating the clinical and radiographic outcomes of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) + Enamel Matrix Derivative (EMD) + Xenograft versus Autogenous Connective Tissue Graft (CTG) + EMD + Xenograft.
Read the detailed description
Background and Objectives:Furcation involvement in multi-rooted teeth presents a significant challenge in periodontal therapy. Precise morphological diagnosis using 3D imaging (CBCT) and effective regenerative strategies are essential to improve tooth prognosis. This study aims to: Determine the prevalence and morphological characteristics of furcation defects in mandibular molars (Cross-sectional component). Compare the diagnostic accuracy of CBCT imaging with direct intra-operative clinical measurements obtained during surgical access (Interventional component). Evaluate and compare the clinical and radiographic efficacy of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft versus Autogenous Connective Tissue Graft (CTG) combined with EMD and xenograft in Hamp Class II furcation defects at 6 months post-operatively. Study Design and Workflow:Component 1 (Cross-Sectional Screening): Stage III/IV periodontitis patients presenting to the Dental Clinic at the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City will be evaluated for the prevalence and morphological features of furcation defects. Component 2 (Randomized Controlled Trial): Following non-surgical periodontal therapy and re-evaluation, 30 patients with residual Hamp Class II furcation defects will be randomly assigned into two treatment groups: Experimental Group: Open flap debridement, placement of xenograft, Acellular Dermal Matrix (ADM), and Enamel Matrix Derivative (EMD). Active Comparator Group: Open flap debridement, placement of xenograft, Autogenous Connective Tissue Graft (CTG), and Enamel Matrix Derivative (EMD). Follow-up: Intra-operative clinical measurements will be compared with pre-operative CBCT scans. Clinical parameters (PPD, CAL) and radiographic bone fill (via CBCT) will be evaluated at baseline and 6 months post-operatively.
- Conditions
- Periodontitis, Periodontitis (Stage 3), Furcation Defects
- Being tested
- Acellular Dermal Matrix + EMD + Xenograft, Autogenous Connective Tissue Graft + EMD + Xenograft
- Keywords
- Periodontal Regeneration, Connective Tissue Graft, Enamel Matrix Derivative, Acellular Dermal Matrix, Cone-Beam Computed Tomography
- Medical subject headings
- Periodontitis, Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal Matrix + EMD + XenograftProcedure or surgery
Surgical debridement of furcation defect, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM).
Autogenous Connective Tissue Graft + EMD + XenograftProcedure or surgery
Surgical debridement of furcation defect, harvesting autogenous connective tissue graft from the palate, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with CTG.
| Study group | Role | What they receive |
|---|---|---|
| ADM + EMD + Xenograft | Experimental | Patients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft. Receives: Procedure: Acellular Dermal Matrix + EMD + Xenograft |
| CTG + EMD + Xenograft | Active comparator | Patients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using autogenous Connective Tissue Graft (CTG) combined with Enamel Matrix Derivative (EMD) and xenograft. Receives: Procedure: Autogenous Connective Tissue Graft + EMD + Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Reduction in probing pocket depth measured in millimeters (mm) at the furcation defect site from the gingival margin to the bottom of the pocket using a UNC-15 probe.
Measured: Baseline and 6 months post-operatively
Change in Clinical Attachment Level (CAL)
Gain in clinical attachment level measured in millimeters (mm) at the furcation defect site from the cementoenamel junction (CEJ).
Measured: Baseline and 6 months post-operatively
Prevalence and Morphological Distribution of Furcation Involvement
Prevalence of furcation defects in mandibular molars among Stage III/IV periodontitis patients and classification of defect severity according to Hamp's classification (Class I, II, and III).
Measured: Baseline (Screening Phase)
Secondary outcomes (6)
Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)
Change in vertical distance from the cementoenamel junction to the base of the bone defect (CEJ-B) measured in millimeters (mm) on CBCT scans.
Measured: Baseline and 6 months post-operatively
Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)
Reduction in horizontal bone loss (H-BL) depth in the furcation area measured in millimeters (mm) on cross-sectional CBCT images.
Measured: Baseline and 6 months post-operatively
Change in Gingival Recession (GR)
Comparison of furcation defect dimensions (in mm) measured on pre-operative CBCT scans against direct clinical measurements obtained during surgery using a K-file (#60) after open flap debridement.
Measured: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Gingival Thickness (GT)
Change in facial gingival thickness measured in millimeters (mm) using an endodontic file with a silicone stop and digital caliper.
Measured: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Keratinized Tissue Height (KTH)
Change in keratinized tissue height measured from the gingival margin to the mucogingival junction in millimeters (mm) following 3% Lugol's iodine staining.
Measured: Baseline, 1 month, 3 months, and 6 months post-operatively
Diagnostic Accuracy of CBCT Imaging Versus Direct Intra-operative Measurements
Comparison of furcation defect dimensions (in mm) measured on pre-operative CBCT scans against direct clinical measurements obtained during surgery using a K-file (#60) after open flap debridement.
Measured: Intra-operatively during surgery (compared against pre-operative baseline CBCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start2 May 2026
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Trung Hung, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770256
- Sponsor's protocol ID
- 26317 - ĐHYD
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 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 made publicly available to protect participant privacy and confidentiality, in accordance with the protocol approved by the Ethics Committee. De-identified aggregate data and main findings will be published in the doctoral dissertation and peer-reviewed scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Characteristics of Furcation Involvement in Mandibular Molars and Efficacy of Regenerative Surgical Treatment: A Cross-Sectional and Interventional Trial
- ClinicalTrials.gov ID
- NCT07770256
- Acronym / sponsor ID
- 26317 - ĐHYD
- Conditions
- Periodontitis, Periodontitis (Stage 3), Furcation Defects
- Keywords
- Periodontal Regeneration, Connective Tissue Graft, Enamel Matrix Derivative, Acellular Dermal Matrix, Cone-Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 18 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 study consists of two components evaluating furcation involvement in mandibular molars among Stage III or Stage IV periodontitis patients. Component 1 is a cross-sectional study evaluating the prevalence and morphological characteristics of Hamp Class II furcation defects during initial screening. Component 2 is a randomized controlled clinical trial in 30 selected patients comparing the diagnostic accuracy of Cone Beam Computed Tomography (CBCT) against direct intra-operative clinical measurements, as well as evaluating the clinical and radiographic outcomes of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) + Enamel Matrix Derivative (EMD) + Xenograft versus Autogenous Connective Tissue Graft (CTG) + EMD + Xenograft.
Detailed description
Background and Objectives:Furcation involvement in multi-rooted teeth presents a significant challenge in periodontal therapy. Precise morphological diagnosis using 3D imaging (CBCT) and effective regenerative strategies are essential to improve tooth prognosis. This study aims to: Determine the prevalence and morphological characteristics of furcation defects in mandibular molars (Cross-sectional component). Compare the diagnostic accuracy of CBCT imaging with direct intra-operative clinical measurements obtained during surgical access (Interventional component). Evaluate and compare the clinical and radiographic efficacy of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft versus Autogenous Connective Tissue Graft (CTG) combined with EMD and xenograft in Hamp Class II furcation defects at 6 months post-operatively. Study Design and Workflow:Component 1 (Cross-Sectional Screening): Stage III/IV periodontitis patients presenting to the Dental Clinic at the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City will be evaluated for the prevalence and morphological features of furcation defects. Component 2 (Randomized Controlled Trial): Following non-surgical periodontal therapy and re-evaluation, 30 patients with residual Hamp Class II furcation defects will be randomly assigned into two treatment groups: Experimental Group: Open flap debridement, placement of xenograft, Acellular Dermal Matrix (ADM), and Enamel Matrix Derivative (EMD). Active Comparator Group: Open flap debridement, placement of xenograft, Autogenous Connective Tissue Graft (CTG), and Enamel Matrix Derivative (EMD). Follow-up: Intra-operative clinical measurements will be compared with pre-operative CBCT scans. Clinical parameters (PPD, CAL) and radiographic bone fill (via CBCT) will be evaluated at baseline and 6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM + EMD + Xenograft | Experimental | Procedure: Acellular Dermal Matrix + EMD + XenograftPatients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft. |
| CTG + EMD + Xenograft | Active comparator | Procedure: Autogenous Connective Tissue Graft + EMD + XenograftPatients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using autogenous Connective Tissue Graft (CTG) combined with Enamel Matrix Derivative (EMD) and xenograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged 18 years or older who signed the informed consent form.
- Diagnosed with Stage III or Stage IV periodontitis according to the 2017 AAP/EFP classification.
- Completed non-surgical periodontal therapy with full-mouth plaque score (FMPS) and bleeding on probing (FMBS) <= 20%.
- Presence of at least one mandibular molar with Hamp Class II furcation involvement (horizontal bone loss > 3 mm without through-and-through communication).
- Target tooth requirements:
Key exclusion criteria (10 listed)
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes, hypertension, cardiovascular disease, severe osteoporosis).
- Pregnant or lactating women.
- Current smokers or individuals who quit smoking less than 6 months prior to enrollment.
- Use of antibiotics, anti-inflammatory agents, or medications affecting bone metabolism (e.g., bisphosphonates, high-dose corticosteroids, anti-resorptive drugs) within the past 3 months.
- Previous periodontal surgery at the evaluation site within the past 6 months.
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 |
|---|---|---|
| Acellular Dermal Matrix + EMD + XenograftSurgical debridement of furcation defect, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM). | Procedure or surgery | ADM + EMD + Xenograft |
| Autogenous Connective Tissue Graft + EMD + XenograftSurgical debridement of furcation defect, harvesting autogenous connective tissue graft from the palate, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with CTG. | Procedure or surgery | CTG + EMD + Xenograft |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 6 months post-operatively
Reduction in probing pocket depth measured in millimeters (mm) at the furcation defect site from the gingival margin to the bottom of the pocket using a UNC-15 probe.
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 6 months post-operatively
Gain in clinical attachment level measured in millimeters (mm) at the furcation defect site from the cementoenamel junction (CEJ).
Prevalence and Morphological Distribution of Furcation Involvement
Time frame: Baseline (Screening Phase)
Prevalence of furcation defects in mandibular molars among Stage III/IV periodontitis patients and classification of defect severity according to Hamp's classification (Class I, II, and III).
6 secondary outcomes
Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)
Time frame: Baseline and 6 months post-operatively
Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)
Time frame: Baseline and 6 months post-operatively
Change in Gingival Recession (GR)
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Gingival Thickness (GT)
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Keratinized Tissue Height (KTH)
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Diagnostic Accuracy of CBCT Imaging Versus Direct Intra-operative Measurements
Time frame: Intra-operatively during surgery (compared against pre-operative baseline CBCT)
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 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available to protect participant privacy and confidentiality, in accordance with the protocol approved by the Ethics Committee. De-identified aggregate data and main findings will be published in the doctoral dissertation and peer-reviewed scientific journals.
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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.
Nga Tran Yen, PhD, DDS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix + EMD + Xenograft and Autogenous Connective Tissue Graft + EMD + Xenograft in people with Periodontitis and Periodontitis (Stage 3), 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 11 inclusion and 10 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 18 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?
Contact Nguyen Trung Hung, MSc, DDS (+84 908248288, nthung.ncs.rhm25@ump.edu.vn), or a site near the patient. 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 post-operatively). The study lists 3 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 18 Aug 2026.