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

Phạm Đình Thiên Khải

Status

Completed

Conditions

Regeneration

Periodontal Diseases

Treatments

Biological: Growth Factor Application (EDTA + EMD)

Procedure: Root Surface Preparation and Debridement

Drug: Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet

Procedure: Suturing Technique

Drug: chlorhexidine mouthrinse

Procedure: Minimally Invasive Flap Design

Drug: Ibuprofen (Advil)

Procedure: Connective Tissue Graft (CTG) Wall Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT07233733

258/2025/HĐ-ĐHYD (Other Grant/Funding Number)

No. 716/HĐĐĐ-ĐHYD

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Connective Tissue Wall + Enamel Matrix Derivative

Experimental group

Description:

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.

Treatment: