Clinical trial NCT07012525: Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
Official title: Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Interdental Papillae Reconstruction
Lead sponsor: Dar Al Uloom University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Type: Interventional (Clinical Trial) Model: Split-Mouth, Parallel Assignment Masking: Single-Blind (Outcomes Assessor) Primary Purpose: Treatment This study follows a split-mouth randomized controlled design, where each participant serves as their own control. The oral cavity is divided into right and left maxillary quadrants. One quadrant (control group) will receive hyaluronic acid (HA) filler only, while the other quadrant (experimental group) will receive HA filler combined with photobiomodulation therapy (PBMT).

This within-subject model minimizes inter-individual variability and allows for more accurate comparison of treatment efficacy between the two modalities. Randomization determines which side receives the PBMT-enhanced therapy. Outcome assessors are blinded to group allocation to reduce bias during follow-up measurements.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study explores a novel, minimally invasive therapeutic approach to treating interdental papillary loss (IDP)-a condition with both functional and esthetic consequences, particularly in the maxillary anterior region. While surgical techniques for papilla regeneration have been investigated for decades, success has been limited due to anatomical challenges such as restricted blood supply and the small volume of tissue involved. Additionally, many of these procedures are invasive, complex, and do not guarantee long-term stability.

The proposed study evaluates the synergistic effect of photobiomodulation therapy (PBMT), formerly known as low-level laser therapy (LLLT), when combined with injectable hyaluronic acid (HA) dermal filler. PBMT is known to enhance microcirculation, stimulate fibroblast activity, and promote angiogenesis, all of which may contribute to improved tissue regeneration. HA, on the other hand, supports extracellular matrix remodeling, tissue hydration, and wound healing. While HA has shown some promise when used alone for papilla reconstruction, recurrence of papillary loss has been reported within 6-12 months post-treatment.

This clinical trial employs a split-mouth, randomized controlled design to compare two interventions within the same patient-HA filler alone versus HA combined with PBMT. By minimizing inter-patient variability, this design enhances internal validity and provides a more reliable comparison of treatment efficacy.

Throughout a 12-month follow-up period, the study will assess changes in papillary height, width, and overall tissue volume using standardized clinical measurements and digital imaging analysis. Additionally, the PBMT group will receive laser therapy at each follow-up session to evaluate its ongoing regenerative contribution.

This study aims to introduce a patient-friendly, conservative alternative to surgical procedures, with the potential to become a predictable and reproducible technique in the esthetic zone. If successful, it may offer a paradigm shift in managing one of the most challenging soft tissue defects in periodontal and esthetic dentistry.

Eligibility criteria: Inclusion Criteria:

* 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
* Healthy periodontal status, with:
* Probing depth ≤ 3 mm
* No gingival recession
* No tooth mobility (Score 0)
* No interdental bone loss on radiographs
* Non-smokers
* No previous orthodontic treatment
* Free from gingival or dental surface alterations (e.g., abfraction, irregularities, or overcontouring)
* Systemically healthy (no systemic diseases or conditions affecting healing or immune function)
* Willing and able to comply with study procedures and follow-up visits
* Provided written informed consent after explanation of study procedures

Exclusion Criteria:

* Candidates will be excluded if they meet any of the following:
* 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
* Current use of anti-inflammatory drugs, anticoagulants, or antibiotics that could affect healing
* Poor oral hygiene or non-compliance during pre-treatment phase
* Participation in another clinical trial within the last 3 months

Primary outcomes:
measure: Change in Papillary Deficient Area
timeFrame: Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Change in Papillary Width
timeFrame: Baseline and follow-up at 1, 3, 6, and 12 months
measure: Change in Papillary Deficient Height
timeFrame: Baseline and follow-up at 1, 3, 6, and 12 months
measure: Digital Image Analysis Score
timeFrame: Baseline and follow-up at 1, 3, 6, and 12 months
measure: Patient Satisfaction and Aesthetic Score
timeFrame: At 3, 6, and 12 months
measure: Incidence of Adverse Effects
timeFrame: throughout the study duration (from initial treatment up to 12 months)
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Dentistry, Dar AlUloom University
Study officials:
affiliation: College of Dentistry, Dar AlUloom University, SA
name: SREIC College of dentistry, Dar AlUloom University
role: STUDY_DIRECTOR
References: