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.
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
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
Parallel
Photobiomodulation Therapy + Hyaluronic Acid Gel Injection
Procedure/SurgeryThis 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
DrugThis 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.
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.
Change in Papillary Width
Measures the horizontal base width of the interdental papilla at the crestal level between adjacent teeth. Assessment Tool: Clinical probing and digital image analysis.
Change in Papillary Deficient Height
Vertical distance (in mm) from the tip of the papilla to the contact point between adjacent teeth. Assessment Tool: Periodontal probe (UNC-15) and digital images.
Digital Image Analysis Score
Quantitative assessment of papillary volume and soft tissue contour using standardized intraoral photographs and imaging software.
Patient Satisfaction and Aesthetic Score
Patient-reported outcomes evaluating satisfaction with esthetics and comfort using a visual analog scale (VAS) from 0 to 10.
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