A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects
NCT ID: NCT07233733
Last Updated: 2025-11-18
Study Results
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Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2024-06-01
2025-08-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Connective Tissue Wall + Enamel Matrix Derivative
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.
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.
Minimally Invasive Flap Design
Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.
Root Surface Preparation and Debridement
Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.
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.
Suturing Technique
Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.
Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.
Ibuprofen (Advil)
400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.
chlorhexidine mouthrinse
0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.
Interventions
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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.
Minimally Invasive Flap Design
Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.
Root Surface Preparation and Debridement
Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.
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.
Suturing Technique
Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.
Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.
Ibuprofen (Advil)
400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.
chlorhexidine mouthrinse
0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Phạm Đình Thiên Khải
OTHER
Responsible Party
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Phạm Đình Thiên Khải
Resident Doctor in Periodontology, Principal Investigator
Locations
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University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Countries
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Other Identifiers
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258/2025/HĐ-ĐHYD
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No. 716/HĐĐĐ-ĐHYD
Identifier Type: -
Identifier Source: org_study_id
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