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

NCT07012525 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 31-05-2024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Interdental Papillae Reconstruction

Outcome Measures

Primary Outcomes (1)

• Change in Papillary Deficient Area

  This outcome measures the change in the total area of interdental papillary deficiency (in mm²), calculated using standardized measurements of papillary height and width. The area is estimated using the formula: Area = ½ × Papillary Width × Papillary Deficient Height. Method of Assessment: Clinical measurements with a UNC-15 probe and digital photographic analysis.

  Baseline, 1 month, 3 months, 6 months, and 12 months

Secondary Outcomes (5)

• Change in Papillary Width

  Baseline and follow-up at 1, 3, 6, and 12 months

• Change in Papillary Deficient Height

  Baseline and follow-up at 1, 3, 6, and 12 months

• Digital Image Analysis Score

  Baseline and follow-up at 1, 3, 6, and 12 months

• Patient Satisfaction and Aesthetic Score

  At 3, 6, and 12 months

• Incidence of Adverse Effects

  throughout the study duration (from initial treatment up to 12 months)

Study Arms (2)

Photobiomodulation + Hyaluronic Acid

EXPERIMENTAL

This arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration.

Procedure: Photobiomodulation Therapy + Hyaluronic Acid Gel Injection

Hyaluronic Acid Gel Injection only

ACTIVE COMPARATOR

This arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm.

Drug: Hyaluronic Acid Gel Injection

Interventions

Photobiomodulation Therapy + Hyaluronic Acid Gel Injection PROCEDURE

This arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration.

Photobiomodulation + Hyaluronic Acid

Hyaluronic Acid Gel Injection DRUG

This arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm.

Hyaluronic Acid Gel Injection only

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dar Al Uloom University: lead

Study Sites (1)

College of Dentistry, Dar AlUloom University

Riyadh, 11512, Saudi Arabia

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• SREIC College of dentistry, Dar AlUloom University

  College of Dentistry, Dar AlUloom University, SA

  STUDY DIRECTOR

Central Study Contacts

Sally A ElHaddad, Assist. Prof.

CONTACT

+966555361062; s.elhaddad@dau.edu.sa

SREIC Scientific Research Ethics and Innovative committee

CONTACT

00966011494; cod.sreic@du.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Periodontology and Oral Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Start Date: Six months after publication of the primary study results in a peer-reviewed journal. End Date: Five years from the IPD availability start date.

Locations

SA (1)