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Periodontal DiseasesCTG + EMDNCT07233733

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

A study testing Connective Tissue Graft (CTG) Wall Technique, Minimally Invasive Flap Design and Root Surface Preparation and Debridement in people with Periodontal Diseases and Regeneration, run by Phạm Đình Thiên Khải at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontal Diseases, Regeneration
What is being tested?
Connective Tissue Graft (CTG) Wall Technique, Minimally Invasive Flap Design and Root Surface Preparation and Debridement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteVietnam
Study dates
1 Jun 2024to 1 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Vietnam1 site
  • University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology

    Ho Chi Minh City, Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

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

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.

Read the 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.

Being tested
Connective Tissue Graft (CTG) Wall Technique, Minimally Invasive Flap Design, Root Surface Preparation and Debridement, Growth Factor Application (EDTA + EMD), Suturing Technique
Keywords
connective tissue, Enamel Matrix Derivative (EMD), Periodontal Regeneration, Infrabony Defects
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connective Tissue Graft (CTG) Wall TechniqueProcedure or surgery

    Also called Connective Tissue Graft 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 DesignProcedure or surgery

    Split-thickness vestibular releasing flap with external papilla reflection to allow coronal advancement and preserve blood supply.

  • Root Surface Preparation and DebridementProcedure or surgery

    Thorough degranulation and root surface debridement using ultrasonic and hand instruments; intraoperative recording of defect depth and morphology.

  • Growth Factor Application (EDTA + EMD)Biological

    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 TechniqueProcedure or surgery

    Combination of horizontal mattress and interrupted sutures to achieve tension-free primary closure.

  • Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral TabletDrug

    875/125 mg orally, twice daily for 5 days, prescribed as postoperative antibiotic therapy.

  • Ibuprofen (Advil)Drug

    400 mg orally, three times daily for 5 days, prescribed for postoperative pain and inflammation control.

  • chlorhexidine mouthrinseDrug

    0.12% solution, twice daily for 2 weeks, prescribed for chemical plaque control.

Study groups in NCT07233733
Study groupRoleWhat they receive
Connective Tissue Wall + Enamel Matrix DerivativeExperimentalPeriodontal regenerative surgery using a connective tissue graft (CTG) "soft-tissue wall" combined with enamel matrix derivative (EMD, Emdogain®) under a minimally invasive flap design.
Receives: Procedure: Connective Tissue Graft (CTG) Wall Technique; Procedure: Minimally Invasive Flap Design; Procedure: Root Surface Preparation and Debridement; Biological: Growth Factor Application (EDTA + EMD); Procedure: Suturing Technique; Drug: Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet; Drug: Ibuprofen (Advil); Drug: chlorhexidine mouthrinse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline 3 months, and 6 months post-surgery

  2. 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.

    Measured: Baseline, one month, 3 months, 6 months

  3. 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.

    Measured: Baseline and 6 months post-surgery

  4. 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.

    Measured: Baseline, 1 month, 3 months, and 6 months post-surgery

  5. Probing Pocket Depth (PPD)

    Distance from gingival margin to base of pocket with UNC-15 probe and stent. Negative change = reduction (better).

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (14)
  1. 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.

    Measured: Baseline, 3 months, 6 months

  2. Early Healing Index (EHI)

    Early wound healing quality assessed according to Wachtel (2003) index. Unit: ordinal scale (1-5). 1 = best, 5 = worst.

    Measured: 1 week, 2 weeks post-surgery

  3. 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.

    Measured: Baseline, 1 month, 3 months, 6 months

  4. 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.

    Measured: Baseline, 1 month, 3 months, 6 months

  5. Defect Angle

    Calculated as the angle formed between the root surface and bone crest at the defect site on CBCT images. Unit: degrees (°). Descriptive.

    Measured: Baseline and 6 months.

  6. 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.

    Measured: Baseline, 6 months.

  7. Suprabony Component

    Distance from CEJ to alveolar bone crest measured on CBCT; indicates vertical bone loss height. Unit: millimeters (mm).

    Measured: Baseline, 6 months

  8. 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

    Measured: Baseline, 6 months

  9. Sex/Gender

    Male and Female

    Measured: At baseline

  10. Age

    Adults, 18 years and older. Unit: years

    Measured: At baseline

  11. Defect Depth at Surgery

    Distance from bonecrest to base of defect measured intraoperatively in mm

    Measured: At surgery

  12. 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.

    Measured: At surgery and baseline

  13. Defect Location

    Categorical (Maxilla / Mandible).

    Measured: At baseline

  14. Tooth Type

    Categorical (Incisor / Canine / Premolar / Molar).

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start1 Jun 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233733
Sponsor's protocol ID
No. 716/HĐĐĐ-ĐHYD
Other IDs
258/2025/HĐ-ĐHYD
Acronym
CTG + EMD
Status last verified
Nov 2025
First submitted
26 Sep 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Connective Tissue Graft (CTG) Wall Technique, Minimally Invasive Flap Design and Root Surface Preparation and Debridement in people with Periodontal Diseases and Regeneration, run by Phạm Đình Thiên Khải at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Attachment Level (CAL) Gain (time frame: Baseline 3 months, and 6 months post-surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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