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

NCT ID: NCT07012525

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-12-30

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.

Conditions

Interdental Papillae Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photobiomodulation + Hyaluronic Acid

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.

Group Type: EXPERIMENTAL

Photobiomodulation Therapy + Hyaluronic Acid Gel Injection

Intervention Type: 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.

Hyaluronic Acid Gel Injection only

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.

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid Gel Injection

Intervention Type: 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.

Interventions

Photobiomodulation Therapy + Hyaluronic Acid Gel Injection

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.

Intervention Type: PROCEDURE

Hyaluronic Acid Gel Injection

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dar Al Uloom University

OTHER

Sponsor Role: lead

Responsible Party

Sally Abd-ElMeniem ElHaddad

Assist. Prof. Periodontology and Oral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SREIC College of dentistry, Dar AlUloom University

Role: STUDY_DIRECTOR

College of Dentistry, Dar AlUloom University, SA

Locations

College of Dentistry, Dar AlUloom University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Sally A ElHaddad, Assist. Prof.

Role: CONTACT

s.elhaddad@dau.edu.sa

+966555361062

SREIC Scientific Research Ethics and Innovative committee

Role: CONTACT

cod.sreic@du.edu.sa

00966011494 ext. 9212

Facility Contacts

Sally ElHaddad, Assist. Prof.

Role: primary

s.elhaddad@dau.edu.sa

00966555361062

Other Identifiers

31-05-2024

Identifier Type: -

Identifier Source: org_study_id