Periodontal Diseases, Regeneration
Conditions
Keywords
connective tissue, Enamel Matrix Derivative (EMD), Periodontal Regeneration, Infrabony Defects
Brief 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.
Interventions
PROCEDUREConnective 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.
PROCEDUREMinimally Invasive Flap Design
Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.
PROCEDURERoot Surface Preparation and Debridement
Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.
BIOLOGICALGrowth 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.
PROCEDURESuturing Technique
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Phạm Đình Thiên Khải
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcome assessors were blinded to the surgical intervention. Examiners responsible for clinical and radiographic measurements were not involved in the surgical procedures and were unaware of the treatment allocation, ensuring unbiased data collection
Intervention model description
This is a single-arm interventional clinical trial in which all enrolled patients receive periodontal regenerative surgery using the connective tissue graft wall technique combined with enamel matrix derivative (Emdogain®). The model was selected to evaluate clinical and radiographic outcomes of this specific surgical approach without a comparator group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) Gain | Baseline 3 months, and 6 months post-surgery | 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). |
| Recession Interproximal (RECi) | Baseline, one month, 3 months, 6 months | 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. |
| Radiographic Intrabony Defect Fill (mm) | Baseline and 6 months post-surgery | 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. |
| Recession Buccal (RECb) | Baseline, 1 month, 3 months, and 6 months post-surgery | 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. |
| Probing Pocket Depth (PPD) | Baseline, 3 months, and 6 months | Distance from gingival margin to base of pocket with UNC-15 probe and stent. Negative change = reduction (better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full-Mouth Bleeding Score (FMBS) | Baseline, 1 month, 3 months, 6 months | Percentage of tooth surfaces with bleeding after probing, assessed according to O'Leary et al. (1972). Unit: percentage (%). Lower = better. |
| Defect Angle | Baseline and 6 months. | Calculated as the angle formed between the root surface and bone crest at the defect site on CBCT images. Unit: degrees (°). Descriptive. |
| Buccal Bone Dehiscence | Baseline, 6 months. | 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. |
| Suprabony Component | Baseline, 6 months | Distance from CEJ to alveolar bone crest measured on CBCT; indicates vertical bone loss height. Unit: millimeters (mm). |
| Tooth Type | At baseline | Categorical (Incisor / Canine / Premolar / Molar). |
| Sex/Gender | At baseline | Male and Female |
| Age | At baseline | Adults, 18 years and older. Unit: years |
| Defect Depth at Surgery | At surgery | Distance from bonecrest to base of defect measured intraoperatively in mm |
| Number of Remaining Bony Walls | At surgery and baseline | 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. |
| Infrabony Defect Depth | Baseline, 6 months | 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 |
| Defect Location | At baseline | Categorical (Maxilla / Mandible). |
| Gingival Thickness | Baseline, 3 months, 6 months | Buccal gingival thickness measured mid-facially using probe transparency method as described by Kan et al. (2003). Unit: categorical (thin / thick). Thick = better. |
| Early Healing Index (EHI) | 1 week, 2 weeks post-surgery | Early wound healing quality assessed according to Wachtel (2003) index. Unit: ordinal scale (1-5). 1 = best, 5 = worst. |
| Full-Mouth Plaque Score (FMPS) | Baseline, 1 month, 3 months, 6 months | Percentage of tooth surfaces with visible plaque after probing, assessed according to O'Leary et al. (1972). Unit: percentage (%). Lower = better. |
Countries
Vietnam
Outcome results
None listed