Clinical Trial

Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique

Not Yet Recruiting Phase 1/2
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Summary
The goal of this clinical trial is to evaluate the effectiveness of a minimally invasive therapy combining photobiomodulation (PBMT) with injectable dermal filler (hyaluronic acid) in adult patients (ages 20-40) with interdental papillary loss (Norland \& Tarnow Class I) in the maxillary anterior region. The main questions it aims to answer are: Does PBMT enhance the regenerative effect of hyaluronic acid filler in restoring the interdental papilla? Is the combined therapy superior to dermal filler alone in achieving long-term aesthetic and clinical stability? Researchers will compare: Group I (control) - hyaluronic acid filler alone vs. Group II (experimental) - PBMT applied before and after hyaluronic acid filler to see if PBMT contributes to better papilla height, width, and volume restoration over 12 months. Participants will: Undergo standard periodontal cleaning and education 4 weeks before treatment Receive local anesthesia and dermal filler injections in both quadrants (split-mouth design) Have PBMT applied in one quadrant only (Group II) Be followed up at regular intervals (1 week to 12 months) for clinical measurements and digital image analysis of papilla dimensions This study introduces a non-surgical, patient-friendly technique that may enhance soft tissue regeneration in esthetic areas, offering a potential breakthrough in managing interdental papillary loss.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-01.
Trial Details
NCT Number NCT07012525
Lead Sponsor Dar Al Uloom University
Conditions Interdental Papillae Reconstruction
Enrollment 14 participants
Start Date 2025-09-15
Primary Completion 2026-12 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-22