PeriodontitisNCT07764029
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
A study testing A-PRF+ and Xenograft and Collagen Membrane and Xenograft in people with Periodontitis and Furcation Defects, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The purpose of this randomized controlled clinical trial is to compare the effectiveness of advanced platelet-rich fibrin (A-PRF+) combined with xenograft versus a collagen membrane combined with xenograft in the treatment of degree II furcation involvements in mandibular first molars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Furcation Defects
- What is being tested?
- A-PRF+ and Xenograft and Collagen Membrane and Xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Jun 2026to 30 Jun 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
- Patients over 18 years old
- Patients diagnosed with periodontitis who have completed non-surgical treatment: scaling and root planing
- Patients attending a follow-up visit at least 5 weeks after non-surgical treatment, demonstrating compliance and good oral hygiene cooperation
- Presence of a mandibular molar with a Degree II furcation involvement according to Hamp (1975), presenting a residual periodontal pocket at the buccal site (PPD ≥ 5mm) after non-surgical treatment, and showing radiolucency in the furcation area on CBCT imaging
- Plaque Index (PlI) < 1 following non-surgical treatment
- Width of keratinized gingiva ≥ 2mm
Show all 10Show fewer
- Teeth with furcation defects where gingival recession does not extend apically beyond the buccal furcation fornix (no supragingival furcation exposure)
- Teeth without occlusal trauma, pulpal or periapical pathologies, and no combined periodontic-endodontic lesions
- Degree II furcation involvement according to Hamp (1975) and Subclass A or B according to Tarnow and Fletcher (1984)
- The defect is located apical to the interproximal alveolar bone crest on CBCT imaging
Who cannot join
- Patients with systemic diseases affecting periodontal treatment outcomes, such as: diabetes mellitus, heart disease requiring anticoagulant therapy, blood disorders, immunodeficiency, etc
- Pregnant or lactating patients
- Patients who have used antibiotics or any other medications affecting periodontal treatment outcomes within the last 6 months
- Patients who smoke tobacco.
- Patients who have used aspirin or medications affecting blood coagulation within 2 weeks prior to the blood collection for PRF preparation
- Patients with a history of allergy to local anesthetics
- Defects associated with grade II tooth mobility that has not been splinted, or grade III tooth mobility according to Miller (2014)
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, Ho Chi Minh City (HCMC), 700000
Thanh Si Ho, Doctor of Dental Surgery, +84944510521, sithanhlk2000@gmail.com
About this study
Official title: Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
The purpose of this randomized controlled clinical trial is to compare the effectiveness of advanced platelet-rich fibrin (A-PRF+) combined with xenograft versus a collagen membrane combined with xenograft in the treatment of degree II furcation involvements in mandibular first molars. Adult patients with periodontitis will randomly receive either the A-PRF+ treatment or the collagen membrane treatment during periodontal flap surgery. The study will evaluate clinical periodontal healing, bone regeneration using 3D imaging (CBCT), patient comfort (pain levels and satisfaction), and changes in the TWEAK biomarker in gingival crevicular fluid over a 6-month period.
Read the detailed description
Furcation involvements in molars pose a significant challenge in periodontal therapy. This study aims to evaluate a regenerative approach using advanced platelet-rich fibrin (A-PRF+) to enhance clinical and radiographic outcomes. The study includes adult patients with periodontitis who have a degree II furcation involvement (Hamp 1975) on a mandibular molar, with a probing pocket depth of ≥ 5mm after initial non-surgical therapy.
Eligible patients will be randomly allocated to one of two surgical interventions:
Test Group: Open flap debridement followed by the application of A-PRF+ mixed with a xenograft (Cerabone), covered by an A-PRF+ membrane.
Control Group: Open flap debridement followed by the application of a xenograft (Cerabone) covered by a resorbable collagen membrane (Guided Tissue Regeneration).
Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Recession (GR), Vertical Clinical Attachment Level (VCAL), and Horizontal Clinical Attachment Level (HCAL) will be recorded at baseline and 6 months post-surgery using customized acrylic stents.
Radiological assessments using Cone Beam Computed Tomography (CBCT) will measure furcation volume, bone fill, and new bone gray level at baseline and 6 months. Patient-reported outcomes, including pain perception (VAS), painkiller consumption, and post-operative satisfaction (Likert scale), will be monitored during the first week. Additionally, Gingival Crevicular Fluid (GCF) samples will be collected to analyze the concentration of the TWEAK biomarker via ELISA at baseline, 1 month, and 3 months post-surgery.
- Conditions
- Periodontitis, Furcation Defects
- Being tested
- A-PRF+ and Xenograft, Collagen Membrane and Xenograft
- Keywords
- A-PRF plus, A-PRF+, Xenograft, Mandibular Molar, Guided Tissue Regeneration, TWEAK, biomarker, collagen membrane
- 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.
A-PRF+ and XenograftProcedure or surgery
Also called Advanced Platelet-Rich Fibrin plus, Cerabone, A-PRF+
Open flap debridement surgery. The furcation defect is filled with a mixture of A-PRF+ fragments and bovine xenograft (Cerabone), and then covered with an A-PRF+ membrane before suturing
Collagen Membrane and XenograftProcedure or surgery
Also called Guided Tissue Regeneration, Bio-Gide, Cerabone, Collagen membrane
Open flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
| Study group | Role | What they receive |
|---|---|---|
| A-PRF+ and Xenograft | Experimental | Open flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane Receives: Procedure: A-PRF+ and Xenograft |
| Collagen Membrane and Xenograft | Active comparator | Open flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane Receives: Procedure: Collagen Membrane and Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Clinical Attachment Level (HCAL)
HCAL is evaluated using a Nabers probe and a customized acrylic stent to measure the horizontal penetration from the buccal furcation entrance to the deepest point of the defect
Measured: Baseline and 6 months post-surgery
Probing Pocket Depth (PPD)
PPD is measured using a UNC-15 periodontal probe and a customized acrylic stent to ensure measurement reproducibility. The measurement is recorded at the buccal aspect of the involved tooth
Measured: Baseline and 6 months post-surgery
Secondary outcomes (11)
Plaque Index (PlI)
Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria
Measured: Baseline, 3 months, and 6 months post-surgery
Gingival Index (GI)
Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation
Measured: Baseline and 6 months post-surgery
Vertical Clinical Attachment Level (VCAL)
Measured using a UNC-15 periodontal probe and a customized acrylic stent
Measured: Baseline and 6 months post-surgery
Gingival Recession (GR)
Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent
Measured: Baseline, 3 months, and 6 months post-surgery
Radiographic Vertical Bone Level (VBL)
Measured on Cone Beam Computed Tomography (CBCT) images from the furcation fornix to the base of the defect
Measured: Baseline and 6 months post-surgery
Furcation Defect Volume
Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)
Measured: Baseline and 6 months post-surgery
New Bone Gray Level
Evaluated using CBCT and ImageJ software to assess the density of newly formed bone
Measured: Baseline and 6 months post-surgery
TWEAK Biomarker Concentration
Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Baseline, 1 month, and 3 months post-surgery
Post-operative Pain Perception
Assessed using a 10-cm Visual Analog Scale (VAS) where 0 indicates "no pain" and 10 indicates "worst imaginable pain"
Measured: 12 hours, 1 day, and 3 days post-surgery
Post-operative Painkiller Consumption
Recorded as the total number of analgesic tablets consumed by the patient
Measured: Up to 3 days post-surgery
Post-operative Patient Satisfaction
Evaluated using a 5-point Likert scale (from 1 = very dissatisfied to 5 = very satisfied) regarding post-operative swelling and chewing ability
Measured: 3 days and 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start25 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- Model description
- Eligible teeth are randomly assigned in parallel to either the test group (A-PRF+ and xenograft) or the control group (collagen membrane and xenograft
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanh Si Ho, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764029
- Sponsor's protocol ID
- 26410 - ĐHYD
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
- ClinicalTrials.gov ID
- NCT07764029
- Acronym / sponsor ID
- 26410 - ĐHYD
- Conditions
- Periodontitis, Furcation Defects
- Keywords
- A-PRF plus, A-PRF+, Xenograft, Mandibular Molar, Guided Tissue Regeneration, TWEAK, biomarker, collagen membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 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.
The purpose of this randomized controlled clinical trial is to compare the effectiveness of advanced platelet-rich fibrin (A-PRF+) combined with xenograft versus a collagen membrane combined with xenograft in the treatment of degree II furcation involvements in mandibular first molars. Adult patients with periodontitis will randomly receive either the A-PRF+ treatment or the collagen membrane treatment during periodontal flap surgery. The study will evaluate clinical periodontal healing, bone regeneration using 3D imaging (CBCT), patient comfort (pain levels and satisfaction), and changes in the TWEAK biomarker in gingival crevicular fluid over a 6-month period.
Detailed description
Furcation involvements in molars pose a significant challenge in periodontal therapy. This study aims to evaluate a regenerative approach using advanced platelet-rich fibrin (A-PRF+) to enhance clinical and radiographic outcomes. The study includes adult patients with periodontitis who have a degree II furcation involvement (Hamp 1975) on a mandibular molar, with a probing pocket depth of ≥ 5mm after initial non-surgical therapy.
Eligible patients will be randomly allocated to one of two surgical interventions:
Test Group: Open flap debridement followed by the application of A-PRF+ mixed with a xenograft (Cerabone), covered by an A-PRF+ membrane.
Control Group: Open flap debridement followed by the application of a xenograft (Cerabone) covered by a resorbable collagen membrane (Guided Tissue Regeneration).
Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Recession (GR), Vertical Clinical Attachment Level (VCAL), and Horizontal Clinical Attachment Level (HCAL) will be recorded at baseline and 6 months post-surgery using customized acrylic stents.
Radiological assessments using Cone Beam Computed Tomography (CBCT) will measure furcation volume, bone fill, and new bone gray level at baseline and 6 months. Patient-reported outcomes, including pain perception (VAS), painkiller consumption, and post-operative satisfaction (Likert scale), will be monitored during the first week. Additionally, Gingival Crevicular Fluid (GCF) samples will be collected to analyze the concentration of the TWEAK biomarker via ELISA at baseline, 1 month, and 3 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible teeth are randomly assigned in parallel to either the test group (A-PRF+ and xenograft) or the control group (collagen membrane and xenograft
| Arm | Type | Receives |
|---|---|---|
| A-PRF+ and Xenograft | Experimental | Procedure: A-PRF+ and XenograftOpen flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane |
| Collagen Membrane and Xenograft | Active comparator | Procedure: Collagen Membrane and XenograftOpen flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients over 18 years old
- Patients diagnosed with periodontitis who have completed non-surgical treatment: scaling and root planing
- Patients attending a follow-up visit at least 5 weeks after non-surgical treatment, demonstrating compliance and good oral hygiene cooperation
- Presence of a mandibular molar with a Degree II furcation involvement according to Hamp (1975), presenting a residual periodontal pocket at the buccal site (PPD ≥ 5mm) after non-surgical treatment, and showing radiolucency in the furcation area on CBCT imaging
- Plaque Index (PlI) < 1 following non-surgical treatment
Key exclusion criteria (7 listed)
- Patients with systemic diseases affecting periodontal treatment outcomes, such as: diabetes mellitus, heart disease requiring anticoagulant therapy, blood disorders, immunodeficiency, etc
- Pregnant or lactating patients
- Patients who have used antibiotics or any other medications affecting periodontal treatment outcomes within the last 6 months
- Patients who smoke tobacco.
- Patients who have used aspirin or medications affecting blood coagulation within 2 weeks prior to the blood collection for PRF preparation
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 |
|---|---|---|
| A-PRF+ and XenograftAlso: Advanced Platelet-Rich Fibrin plus, Cerabone, A-PRF+Open flap debridement surgery. The furcation defect is filled with a mixture of A-PRF+ fragments and bovine xenograft (Cerabone), and then covered with an A-PRF+ membrane before suturing | Procedure or surgery | A-PRF+ and Xenograft |
| Collagen Membrane and XenograftAlso: Guided Tissue Regeneration, Bio-Gide, Cerabone, Collagen membraneOpen flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing | Procedure or surgery | Collagen Membrane and Xenograft |
Primary outcome
Horizontal Clinical Attachment Level (HCAL)
Time frame: Baseline and 6 months post-surgery
HCAL is evaluated using a Nabers probe and a customized acrylic stent to measure the horizontal penetration from the buccal furcation entrance to the deepest point of the defect
Probing Pocket Depth (PPD)
Time frame: Baseline and 6 months post-surgery
PPD is measured using a UNC-15 periodontal probe and a customized acrylic stent to ensure measurement reproducibility. The measurement is recorded at the buccal aspect of the involved tooth
11 secondary outcomes
Plaque Index (PlI)
Time frame: Baseline, 3 months, and 6 months post-surgery
Gingival Index (GI)
Time frame: Baseline and 6 months post-surgery
Vertical Clinical Attachment Level (VCAL)
Time frame: Baseline and 6 months post-surgery
Gingival Recession (GR)
Time frame: Baseline, 3 months, and 6 months post-surgery
Radiographic Vertical Bone Level (VBL)
Time frame: Baseline and 6 months post-surgery
Furcation Defect Volume
Time frame: Baseline and 6 months post-surgery
New Bone Gray Level
Time frame: Baseline and 6 months post-surgery
TWEAK Biomarker Concentration
Time frame: Baseline, 1 month, and 3 months post-surgery
Post-operative Pain Perception
Time frame: 12 hours, 1 day, and 3 days post-surgery
Post-operative Painkiller Consumption
Time frame: Up to 3 days post-surgery
Post-operative Patient Satisfaction
Time frame: 3 days and 7 days post-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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 A-PRF+ and Xenograft and Collagen Membrane and Xenograft in people with Periodontitis and Furcation Defects, 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 10 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 14 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 Thanh Si Ho, Doctor of Dental Surgery (+84944510521, sithanhlk2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Clinical Attachment Level (HCAL) (time frame: Baseline and 6 months post-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 14 Aug 2026.