NCT07233733

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Phạm Đình Thiên Khải · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Periodontal Diseases
• Regeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-03-01
• Completion: 2025-08-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Vietnam