CompletedNot Applicable

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

Vietnam17 participantsStarted 2024-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Attachment Level (CAL) Gain

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

Recession Interproximal (RECi)

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

Radiographic Intrabony Defect Fill (mm)

Timeframe: Baseline and 6 months post-surgery

Recession Buccal (RECb)

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

Probing Pocket Depth (PPD)

Timeframe: Baseline, 3 months, and 6 months

Trial details

NCT IDNCT07233733

SponsorPhạm Đình Thiên Khải

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

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