A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects (CTG + EMD)

November 16, 2025 updated by: Phạm Đình Thiên Khải

Efficacy of Connective Tissue Graft Wall Technique and Enamel Matrix Derivative in the Regenerative Treatment of Intrabony Periodontal Defects: A Prospective Clinical Study

This clinical study aims to evaluate the effectiveness of periodontal regenerative surgery using the connective tissue graft (CTG) wall technique combined with enamel matrix derivative (EMD) in patients who have intrabony periodontal defects. The purpose is to determine whether this combined approach can enhance both bone regeneration and soft-tissue stability compared with the patient's initial condition.

Eligible participants will receive periodontal surgery in which a connective tissue graft and enamel matrix derivative are applied to the defect site. The study will monitor clinical improvements such as attachment gain, reduction in pocket depth, bone fill observed on cone-beam computed tomography (CBCT), and stability of the gingival margin and soft-tissue thickness. Clinical parameters (probing depth and attachment level) are recorded at baseline, 3 months, and 6 months. Gingival and hygiene parameters (recession, gingival thickness, plaque, and bleeding scores) are assessed at baseline, 1 month, 3 months, and 6 months. Radiographic bone outcomes are measured at baseline and 6 months, and early wound healing is assessed at 1 and 2 weeks.

The main goal is to assess whether CTG + EMD treatment provides predictable periodontal regeneration, improved tissue stability, and better esthetic outcomes for patients with periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single-group interventional clinical trial conducted at the University of Medicine and Pharmacy at Ho Chi Minh City to evaluate the effectiveness of the connective tissue graft (CTG) wall technique combined with enamel matrix derivative (EMD, Emdogain®, Straumann) in the regenerative treatment of intrabony periodontal defects. The study included 17 patients diagnosed with stage III-IV periodontitis who presented with radiographically confirmed intrabony defects suitable for regenerative therapy.

All participants received treatment following a standardized periodontal surgical protocol. After local anesthesia, a split-thickness vestibular releasing flap was prepared to allow coronal advancement, with external reflection of the papilla at the defect site. Thorough degranulation and root surface debridement were performed using ultrasonic and hand instruments. The root surface was conditioned with 24% EDTA gel for 2 minutes, rinsed with saline, and then enamel matrix derivative was applied onto the root surface and into the defect. A palatal connective tissue graft harvested using the four-incision technique was de-epithelialized, trimmed to span the papillae, and sutured to the buccal flap to form a stable soft-tissue wall. The flap was coronally advanced and secured with horizontal mattress and interrupted sutures to achieve tension-free primary closure.

Clinical and radiographic outcomes are evaluated at multiple time points.

Clinical parameters: probing pocket depth (PPD) and clinical attachment level (CAL) at baseline, 3 months, and 6 months.

Soft-tissue and hygiene parameters: gingival recession (buccal and interproximal), gingival thickness, full-mouth plaque score (FMPS), and full-mouth bleeding score (FMBS) at baseline, 1, 3, and 6 months.

Radiographic parameters: infrabony defect depth, buccal bone dehiscence, suprabony component, and defect angle measured on cone-beam computed tomography (CBCT) at baseline and 6 months.

Early wound healing: assessed at 1 and 2 weeks using the Early Healing Index (EHI).

The study was conducted at the Department of Periodontology, University of Medicine and Pharmacy at Ho Chi Minh City, between June 2024 and August 2025. The protocol was reviewed and approved by the Institutional Review Board of the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 716/HĐĐĐ-ĐHYD, dated June 13, 2024). All participants provided written informed consent before enrollment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
        • University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥18 years old who can provide written informed consent.
  • Diagnosis of stage III-IV periodontitis (2017 World Workshop).
  • Completed initial non-surgical periodontal therapy with good plaque control.
  • Full-mouth plaque score (FMPS) ≤20% and full-mouth bleeding score (FMBS) ≤20%.
  • Presence of ≥1 intrabony periodontal defect with an intrabony component ≥3 mm, confirmed clinically and radiographically.
  • Probing pocket depth (PPD) at the study site ≥6 mm.

Exclusion Criteria:

  • Systemic conditions or medications that could affect periodontal healing (e.g., diabetes mellitus, immunodeficiency, bisphosphonates, corticosteroids, immunosuppressants).
  • Current smokers or former heavy smokers.
  • Pregnancy or lactation.
  • Teeth with untreated endodontic lesions or non-vital status; furcation involvement class II-III.
  • Untreated occlusal trauma or tooth mobility grade II-III.
  • Third molars.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Connective Tissue Wall + Enamel Matrix Derivative
Periodontal regenerative surgery using a connective tissue graft (CTG) "soft-tissue wall" combined with enamel matrix derivative (EMD, Emdogain®) under a minimally invasive flap design.
Procedure: Connective Tissue Graft (CTG) Wall Technique
After flap elevation and thorough degranulation/root debridement, a palatal connective tissue graft is harvested with the four-incision technique, de-epithelialized, and adapted to the buccal flap to create a stable soft-tissue wall.
Other Names:
  • Connective Tissue Graft Wall Technique
Procedure: Minimally Invasive Flap Design
Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.
Procedure: Root Surface Preparation and Debridement
Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.
Biological: Growth Factor Application (EDTA + EMD)
Conditioning of the root surface with 24% EDTA gel for 2 minutes, rinsing, followed by application of enamel matrix derivative (EMD; Emdogain®) to the root surface and into the intrabony defect.
Procedure: Suturing Technique
Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.
Drug: Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.
Drug: Ibuprofen (Advil)
400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.
Drug: chlorhexidine mouthrinse
0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level (CAL) Gain
Time Frame: Baseline 3 months, and 6 months post-surgery
Change in clinical attachment level measured at the treated intrabony periodontal defect, measured with UNC-15 probe and acrylic stent. The CAL is recorded as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Unit: millimeters (mm). Negative change = gain (better).
Baseline 3 months, and 6 months post-surgery
Recession Interproximal (RECi)
Time Frame: Baseline, one month, 3 months, 6 months
Distance from the cusp tip or incisal edge to the interproximal gingival margin, measured in millimeters, to evaluate changes in papillary and proximal soft tissue level after treatment. Unit: millimeters (mm). Higher = worse.
Baseline, one month, 3 months, 6 months
Radiographic Intrabony Defect Fill (mm)
Time Frame: Baseline and 6 months post-surgery
Change in vertical depth of the intrabony periodontal defect measured on CBCT at the treated site. Linear distance from the alveolar crest to the base of the defect along the root surface is recorded; greater positive values indicate more defect fill. Unit: millimeters (mm). Positive fill = better.
Baseline and 6 months post-surgery
Recession Buccal (RECb)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-surgery
Distance from the cusp tip or incisal edge to the buccal gingival margin (zenith point), measured in millimeters, to evaluate changes in papillary and proximal soft tissue level after treatment. Unit: millimeters (mm). Higher = worse.
Baseline, 1 month, 3 months, and 6 months post-surgery
Probing Pocket Depth (PPD)
Time Frame: Baseline, 3 months, and 6 months
Distance from gingival margin to base of pocket with UNC-15 probe and stent. Negative change = reduction (better).
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival Thickness
Time Frame: Baseline, 3 months, 6 months
Buccal gingival thickness measured mid-facially using probe transparency method as described by Kan et al. (2003). Unit: categorical (thin / thick). Thick = better.
Baseline, 3 months, 6 months
Early Healing Index (EHI)
Time Frame: 1 week, 2 weeks post-surgery
Early wound healing quality assessed according to Wachtel (2003) index. Unit: ordinal scale (1-5). 1 = best, 5 = worst.
1 week, 2 weeks post-surgery
Full-Mouth Plaque Score (FMPS)
Time Frame: Baseline, 1 month, 3 months, 6 months
Percentage of tooth surfaces with visible plaque after probing, assessed according to O'Leary et al. (1972). Unit: percentage (%). Lower = better.
Baseline, 1 month, 3 months, 6 months
Full-Mouth Bleeding Score (FMBS)
Time Frame: Baseline, 1 month, 3 months, 6 months
Percentage of tooth surfaces with bleeding after probing, assessed according to O'Leary et al. (1972). Unit: percentage (%). Lower = better.
Baseline, 1 month, 3 months, 6 months
Defect Angle
Time Frame: Baseline and 6 months.
Calculated as the angle formed between the root surface and bone crest at the defect site on CBCT images. Unit: degrees (°). Descriptive.
Baseline and 6 months.
Buccal Bone Dehiscence
Time Frame: Baseline, 6 months.
Vertical distance from CEJ to the most apical part of buccal bone crest measured on CBCT to assess buccal bone resorption. Unit: millimeters (mm). Lower = better.
Baseline, 6 months.
Suprabony Component
Time Frame: Baseline, 6 months
Distance from CEJ to alveolar bone crest measured on CBCT; indicates vertical bone loss height. Unit: millimeters (mm).
Baseline, 6 months
Infrabony Defect Depth
Time Frame: Baseline, 6 months
Distance from the cemento-enamel junction (CEJ) to the base of the defect measured on CBCT; used to calculate defect depth. Unit: millimeters (mm). Descriptive
Baseline, 6 months
Sex/Gender
Time Frame: At baseline
Male and Female
At baseline
Age
Time Frame: At baseline
Adults, 18 years and older. Unit: years
At baseline
Defect Depth at Surgery
Time Frame: At surgery
Distance from bonecrest to base of defect measured intraoperatively in mm
At surgery
Number of Remaining Bony Walls
Time Frame: At surgery and baseline
Number of residual bony walls at the intrabony defect, assessed intraoperatively. This classification follows the standard defect morphology description used by Tonetti et al. (1993, 1996). A lower number of walls indicates a less favorable prognosis, while a higher number indicates better regenerative potential.
At surgery and baseline
Defect Location
Time Frame: At baseline
Categorical (Maxilla / Mandible).
At baseline
Tooth Type
Time Frame: At baseline
Categorical (Incisor / Canine / Premolar / Molar).
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phạm Đình Thiên Khải

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • No. 716/HĐĐĐ-ĐHYD
  • 258/2025/HĐ-ĐHYD (Other Grant/Funding Number: University of Medicine and Pharmacy at Ho Chi Minh City)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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