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

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

Interventions

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.

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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

  collaborator OTHER

• Phạm Đình Thiên Khải

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-03-01

Completion

2025-08-01

Countries

• Vietnam

Study Locations