Clinical trial NCT06978036: Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery
Periodontal Regeneration
Keywords: Periodontitis
Intrabondy defects
Perioscope
Perioscopy
endoscope-assisted
regeneration
papilla preservation
enamel matrix derivative
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded randomized non-inferiority controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: ΔCAL - 12 months
timeFrame: 12 months
Secondary outcomes:
measure: ΔCAL - 6 months
timeFrame: 6 months
measure: ΔCAL - 9 months
timeFrame: 9 months
measure: FMPS
timeFrame: 3, 6, 9, 12 months
measure: FMBOP
timeFrame: 3, 6, 9, 12 months
measure: ΔREC
timeFrame: 3, 6, 9, 12 months
measure: ΔPPD
timeFrame: 6, 9, 12 months
measure: Mob
timeFrame: 3, 6, 9, 12 months
measure: EWHI
timeFrame: 3, 6, 9, 12 months
measure: ΔINFRA
timeFrame: 3, 6, 9, 12 months
measure: TIME
timeFrame: Measured throughout procedure
measure: % of sites achieving therapeutic endpoints
timeFrame: 6, 9, 12 months
measure: Patient-reported outcome measurements
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Intra-operative Discomfort
timeFrame: 14 days
measure: Daily intake of analgesia
timeFrame: 14 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: