Hyaluronic acid to improve healing after endodontic microsurgery
Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT
This trial will test whether adding cross-linked hyaluronic acid during endodontic microsurgery helps adults with apical periodontitis of first molars heal faster and have less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07501585 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blinded, parallel-group trial comparing endodontic microsurgery with adjunctive cross-linked hyaluronic acid versus the same surgery without the adjunct in adults with persistent apical periodontitis of first molars. Eligible patients previously treated with non-surgical root canal therapy are allocated to test or control groups and followed for 12 months. Primary outcomes are early soft-tissue healing (Early Wound Healing Score at day 4) and postoperative pain (visual analogue scale), with secondary radiographic healing assessments at 3, 6, and 12 months including CBCT. Blinded outcome examiners evaluate radiographs to determine differences in hard-tissue healing.
Who should consider this trial
Good fit: Adults (≥18) with apical periodontitis of a maxillary or mandibular first molar at least 12 months after non-surgical endodontic treatment, good oral hygiene (FMPS and BoP ≤20%), a periapical lesion ≤10 mm, and a four-wall bone defect are ideal candidates.
Not a fit: Patients who are heavy smokers (>10 cigarettes/day), allergic to hyaluronic acid, pregnant or lactating, have uncontrolled diabetes, untreated periodontal disease, acute infections at the surgical site, or lesions/defects that do not meet the size or morphology criteria are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adjunctive cross-linked hyaluronic acid could speed soft- and hard-tissue healing, reduce postoperative pain, and improve the long-term stability of surgical outcomes.
How similar studies have performed: Hyaluronic acid has shown promising soft-tissue healing benefits in oral and periodontal surgery, but robust randomized evidence specifically in endodontic microsurgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * ≥18 years of age * Apical peridontitis at maxillar or mandibular first molars ≥ 12 months after non-surgical endodontical treatment * Full mouth plaque score (FMPS) and bleeding score (BoP) \< or 20% * Periapical lesion \< or 10 mm * Four-wall bone defect morphology Exclusion Criteria: * Smokers of more than 10 cigarettes a day * Allergy to hyaluronic acid * Pregnancy or lactation * Uncontrolled Diabetes * Untreated periodontal conditions * Any conditions associated with poor compliance or failure to maintain good oral hygiene * Acute infections lesions in areas intended for surgery * Chemotherapy and radiotherapy treatment
Where this trial is running
Moscow
- Praktika 1 — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Anton Sculean, Prof.
- Email: anton.sculean@unibe.ch
- Phone: +41316840620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.