A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects

NCT07233733 | Completed DMC

• 2 other identifiers: No. 716/HĐĐĐ-ĐHYD258/2025/HĐ-ĐHYD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Regeneration

Keywords

connective tissue; Enamel Matrix Derivative (EMD); Periodontal Regeneration; Infrabony Defects

Outcome Measures

Primary Outcomes (5)

• Clinical Attachment Level (CAL) Gain

  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)

  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)

  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)

  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)

  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 Outcomes (14)

• Gingival Thickness

  Baseline, 3 months, 6 months

• Early Healing Index (EHI)

  1 week, 2 weeks post-surgery

• Full-Mouth Plaque Score (FMPS)

  Baseline, 1 month, 3 months, 6 months

• Full-Mouth Bleeding Score (FMBS)

  Baseline, 1 month, 3 months, 6 months

• Defect Angle

  Baseline and 6 months.

Study Arms (1)

Connective Tissue Wall + Enamel Matrix Derivative

EXPERIMENTAL

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; Procedure: Minimally Invasive Flap Design; Procedure: Root Surface Preparation and Debridement; Biological: Growth Factor Application (EDTA + EMD); Procedure: Suturing Technique; Drug: Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet; Drug: Ibuprofen (Advil); Drug: chlorhexidine mouthrinse

Interventions

Connective Tissue Graft (CTG) Wall Technique PROCEDURE

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.

Also known as: Connective Tissue Graft Wall Technique

Connective Tissue Wall + Enamel Matrix Derivative

Minimally Invasive Flap Design PROCEDURE

Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.

Connective Tissue Wall + Enamel Matrix Derivative

Root Surface Preparation and Debridement PROCEDURE

Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.

Connective Tissue Wall + Enamel Matrix Derivative

Growth Factor Application (EDTA + EMD) BIOLOGICAL

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.

Connective Tissue Wall + Enamel Matrix Derivative

Suturing Technique PROCEDURE

Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.

Connective Tissue Wall + Enamel Matrix Derivative

Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet DRUG

875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.

Connective Tissue Wall + Enamel Matrix Derivative

Ibuprofen (Advil) DRUG

400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.

Connective Tissue Wall + Enamel Matrix Derivative

chlorhexidine mouthrinse DRUG

0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.

Connective Tissue Wall + Enamel Matrix Derivative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phạm Đình Thiên Khải: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Debridement; Edetic Acid; emerin; Suture Techniques; Amoxicillin; Clavulanic Acid; Ibuprofen

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Wound Closure Techniques; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids; Phenylpropionates; Acids, Carbocyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors were blinded to the surgical intervention. Examiners responsible for clinical and radiographic measurements were not involved in the surgical procedures and were unaware of the treatment allocation, ensuring unbiased data collection
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor in Periodontology, Principal Investigator

Model Details: This is a single-arm interventional clinical trial in which all enrolled patients receive periodontal regenerative surgery using the connective tissue graft wall technique combined with enamel matrix derivative (Emdogain®). The model was selected to evaluate clinical and radiographic outcomes of this specific surgical approach without a comparator group

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 18, 2025
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)