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

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: Completed
• Conditions: Periodontal Diseases; Regeneration
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Thickness	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)	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)	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)	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	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	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	Distance from CEJ to alveolar bone crest measured on CBCT; indicates vertical bone loss height. Unit: millimeters (mm).	Baseline, 6 months
Infrabony Defect Depth	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	Male and Female	At baseline
Age	Adults, 18 years and older. Unit: years	At baseline
Defect Depth at Surgery	Distance from bonecrest to base of defect measured intraoperatively in mm	At surgery
Number of Remaining Bony Walls	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	Categorical (Maxilla / Mandible).	At baseline
Tooth Type	Categorical (Incisor / Canine / Premolar / Molar).	At baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: connective tissue; Periodontal Regeneration; Enamel Matrix Derivative (EMD); Infrabony Defects
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Surgical Procedures, Operative; Acids, Acyclic; Carboxylic Acids; Amides; Amines; Acids, Carbocyclic; Penicillin G; beta-Lactams; Lactams; Clavulanic Acids; Acetates; Ampicillin; Penicillins; Ethylenediamines; Diamines; Polyamines; Phenylpropionates; Wound Closure Techniques; Amoxicillin; Ibuprofen; Clavulanic Acid; Edetic Acid; Debridement; emerin; Suture Techniques
• Other Study ID 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