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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.
Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.
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.
Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.
875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.
400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.
0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.
University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology
Ho Chi Minh City, Ho Chi Minh City, Vietnam
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 3 months, and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months.
Suprabony Component
Distance from CEJ to alveolar bone crest measured on CBCT; indicates vertical bone loss height. Unit: millimeters (mm).
Time frame: 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
Time frame: Baseline, 6 months
Sex/Gender
Male and Female
Time frame: At baseline
Age
Adults, 18 years and older. Unit: years
Time frame: At baseline
Defect Depth at Surgery
Distance from bonecrest to base of defect measured intraoperatively in mm
Time frame: 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.
Time frame: At surgery and baseline
Defect Location
Categorical (Maxilla / Mandible).
Time frame: At baseline
Tooth Type
Categorical (Incisor / Canine / Premolar / Molar).
Time frame: At baseline
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