Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration.

Официальное название

Single-blinded Randomized Non-inferiority Controlled Clinical Trial Comparing Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration of Intra-bony Periodontal Defects

Обзор

The standard of care for regeneration of lost periodontal tissue from disease at contained defect sites non-responding to non-surgical periodontal therapy is periodontal regenerative surgery. The classical practice of periodontal regeneration involves an open flap surgical approach with the the application of biologics (Enamel matrix derivatives EMD) and biomaterials after root surface debridement. EMD, derived from porcine, has been well documented for its safety and efficacy and widely used in periodontal regeneration. There is some evidence demonstrating promising treatment outcome of the flapless application of periodontal regenerative biologics after nonsurgical subgingival debridement. Endoscopic-Assisted Subgingival Debridement EASD with a high magnification up to 40X has been shown to be a non-inferior nonsurgical treatment alternative to open flap debridement with shorter operation times and better early wound healing. We hypothesize that EASD could be integrated into flapless periodontal regeneration to improve clinical performance, patient comfort and acceptance to regenerative procedures. Hence, the focus of this study is to investigate whether flapless application of EMD as an adjunct to EASD can achieve non-inferior clinical results compared to classical open-flap periodontal regeneration using Papilla Preservation Surgical Technique PPT in managing residual periodontal intrabony defects 1 year after intervention. Half of the patients will be randomized to recieve EASD and flapless regneration with EMD, while the other half of the patient will receive classical regeneration with PPT and EMD.

Вмешательства

• Процедура Flapless periodontal regeneration with EMD + EASD
  Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
• Процедура Periodontal regeneration with EMD + PPT
  Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique

Первичные конечные точки

• ΔCAL - 12 months [Срок оценки: 12 months]

Вторичные конечные точки (12)

• ΔCAL - 6 months [Срок оценки: 6 months]
• ΔCAL - 9 months [Срок оценки: 9 months]
• FMPS [Срок оценки: 3, 6, 9, 12 months]
• FMBOP [Срок оценки: 3, 6, 9, 12 months]
• ΔREC [Срок оценки: 3, 6, 9, 12 months]
• ΔPPD [Срок оценки: 6, 9, 12 months]
• Mob [Срок оценки: 3, 6, 9, 12 months]
• EWHI [Срок оценки: 3, 6, 9, 12 months]
• ΔINFRA [Срок оценки: 3, 6, 9, 12 months]
• TIME [Срок оценки: Measured throughout procedure]
• % of sites achieving therapeutic endpoints [Срок оценки: 6, 9, 12 months]
• Patient-reported outcome measurements [Срок оценки: Baseline, 3, 6, 9, 12 months]

Критерии участия

Критерии включения

• Stage III - Stage IV Periodontitis patients, 3-4 months after completing steps I \& II periodontal therapy.
• At least 1 tooth presented with 1 site with >5mm residual PPD and ≥6mm CAL, with ≥3mm intra-osseous defect presented involving predominantly the interdental space of the tooth and presented on paralleling periapical radiographs and/or CBCT.
• Presence of a periodontally stable tooth with PPD≤3mm immediate adjacent to the intra-bony defect of the investigated tooth
• Good Oral Hygiene, with Full Mouth Plaque Score ≤25% at baseline and with good plaque control at proposed surgical field.

Критерии исключения

• Pre-study period

• Any systemic condition which prevents following the study protocol;
• Any systemic condition which may affect healing outcomes of patients, e.g. uncontrolled or poorly controlled diabetes, unstable or life-threatening conditions or those requiring antibiotic prophylaxis;
• Patients under long-term analgesic medication;
• Current smokers;
• Self-reported pregnancy;
• Systemic antimicrobial therapy within 3 months;
• Teeth that concurrently present with a buccal and a lingual intrabony defect component;
• Tooth with hopeless prognosis or questionable prognosis associated with endodontic lesions, or subgingival restorations that preclude clinical measurements, or excessive uncontrolled mobility;
• Any factors which prohibit regular performance of plaque control around surgical sites;
• Inadeduate oral hygiene with full mouth plaque score >25%
• Furcation involved surfaces
• During study period -Non-compliance with study protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong — Гонконг

Публикации

• Ho DKL, Fok MR, Lau XW, Leung WK, Zhang JC, Pelekos G. Single-blinded randomized non-inferiority controlled clinical trial comparing endoscope-assisted flapless approach versus papillary preservation technique in periodontal regeneration of intrabony periodontal defects: study protocol. Trials. 2026 Feb 26;27(1):263. doi: 10.1186/s13063-026-09581-y. PMID 41749350

Идентификаторы

NCT: NCT06978036 · P&ID2025_02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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