Gum disease repair: could a hyaluronic acid gel rival the gold standard?

NCT ID NCT04274244

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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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