Gum disease repair: could a hyaluronic acid gel rival the gold standard?
NCT ID NCT04274244
First seen Jul 07, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This study tests whether a gel made from cross-linked hyaluronic acid (Hyadent BG®) can help regrow bone and gum tissue destroyed by chronic gum disease, comparing it to a standard treatment called Emdogain®. About 53 adults with moderate periodontitis will receive one of the two gels during a minimally invasive surgical procedure. Researchers will measure changes in gum attachment and bone levels over time to see which approach works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cross-linked hyaluronic acid 1.8% gel (Hyadent BG®)
- What this could lead to
- If effective, this gel could offer a simpler, less costly option to regenerate bone and gum tissue lost to periodontitis.
- What could go wrong
- This is a small, early-phase comparison study. Results may not apply to all patients, and the gel may not work as well as the standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
53 people
The number who actually took part.
- Started
-
Mar 2020
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Periodontitis stage II or III, grade A or B: based on the "Consensus report of workgroup of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" Tonetti 2017. Clinical attachment loss of 3-5mm, radiographic bone loss to the middle third, loss of teeth ≤4 due to periodontitis, probing depth ≥ 6 mm. 2. At least, 20 teeth in the mouth. 3. Plaque Index (PI) \< 1, following initial nonsurgical periodontal therapy and hygiene instructions. 4. At least one interproximal 2, 3-wall bone defect with moderate to deep intrabony defects (≥3mm) on the radiographs, and clinical probing depths (PD) \>5mm using William's graduated periodontal probe on premolars or molars following initial nonsurgical periodontal therapy. 5. Absence of caries or overflowing restorations and periapical injuries of the target tooth. 6. Non-smokers. 7. Absence of systemic disease. 8. Negative history for pregnancy 9. No relevant medical history that contraindicate periodontal surgery. 10. All participants signed an inform consent form. 11. The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated. 12. The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study. Exclusion Criteria: 1. The participant is pregnant or lactating or plans to become pregnant within the next 6 months. 2. Heavy smoker (\>10 cigarettes/day). 3. The participant takes\> 4 U of alcohol / day. 4. The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol. 5. Taking drugs that could alter the participant's response in healing or with oral concomitant manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy. 6. Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis. 7. Allergies to drug compounds. 8. The participant has been treated with antibiotics within 3 months before starting the study or has any other systemic condition that requires antibiotic coverage for routine periodontal procedures (eg, heart disease, prosthetic joints, etc.). 9. Participants should not have received periodontal tretment within the 6-month period prior to study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Valencia
Valencia, Valencia, 46010, Spain
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Other studies related to the condition(s) this trial covers.
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