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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-40
SponsorDar Al Uloom University

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 20 to 40 years

Presence of at least two non-adjacent interdental papilla defects (Class I, Norland & Tarnow classification) in the maxillary anterior region

Probing depth ≤ 3 mm

No gingival recession

Disqualifiers

Systemic diseases or medications known to affect soft tissue healing (e.g., diabetes, immunosuppressants)

Pregnancy or lactation

History of periodontal surgery in the study area

Known allergy or hypersensitivity to hyaluronic acid or local anesthetics

Trial design

Treatments tested in this trial

  • Photobiomodulation Therapy + Hyaluronic Acid Gel Injection
  • Hyaluronic Acid Gel Injection

Treatment groups

14 Participants
are divided into 2 treatment groups

Sponsors and collaborators