Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: … (NCT07012525) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
Saudi Arabia14 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
20 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.