Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07501585

Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery A Randomized Clinical Trial

Led by University of Bern · Updated on 2026-03-30

46

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of cross-linked hyaluronic acid as an addition to endodontic microsurgery in adults with apical periodontitis affecting first molars in the upper or lower jaw. This randomized clinical trial aims to determine if the addition of this material improves soft and hard tissue healing, reduces inflammation and pain after surgery, and supports more stable outcomes over 12 months of follow-up. The study hypothesis is that cross-linked hyaluronic acid may provide regenerative and anti-inflammatory benefits in this dental surgery context. Participants previously treated with non-surgical root canal therapy will be randomly assigned to one of two groups. The test group will receive endodontic microsurgery combined with the application of cross-linked hyaluronic acid into the bone defect and under the flap before closure. The control group will undergo the same surgical procedure without the addition of any grafting or regenerative material. All surgeries will be done under local anesthesia and an operating microscope, following a standardized microsurgical protocol including flap elevation, root-end resection, retrograde preparation, filling, and suturing. During the study, participants will be monitored for early soft tissue healing at four days after surgery using a wound healing score and for postoperative pain with a visual analogue scale over the first two weeks. Longer-term assessments will include evaluation of bone healing through radiographs and cone beam CT scans at 3, 6, and 12 months, as well as cortical plate healing. The total follow-up period is 12 months. Safety and healing outcomes will be carefully observed to provide clinical evidence on the effects of adjunctive cross-linked hyaluronic acid in endodontic microsurgery.

CONDITIONS

Brief Title

Hyaluronic Acid in Endodontic Microsurgery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent
  • Age 18 years or older
  • Diagnosed with apical periodontitis at maxillary or mandibular first molars at least 12 months after non-surgical endodontic treatment
  • Full mouth plaque score (FMPS) and bleeding score (BoP) less than or equal to 20%
  • Periapical lesion size less than or equal to 10 mm
  • Presence of a four-wall bone defect morphology
Not Eligible

You will not qualify if you...

  • Smoking more than 10 cigarettes per day
  • Allergy to hyaluronic acid
  • Pregnancy or lactation
  • Uncontrolled diabetes
  • Untreated periodontal conditions
  • Conditions associated with poor compliance or inability to maintain good oral hygiene
  • Acute infections in areas planned for surgery
  • Receiving chemotherapy or radiotherapy treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day surgical procedure with postoperative monitoring up to 2 weeks

Participants undergo endodontic microsurgery. The test group receives adjunctive application of cross-linked hyaluronic acid during surgery, while the control group undergoes standard endodontic microsurgery without adjunctive material.

1 surgical visit and multiple visits within 2 weeks post-surgery for pain and healing assessment

Follow-up

Duration - 12 months

Participants are monitored for healing outcomes and postoperative recovery including pain assessment and imaging evaluations.

Visits at 3, 6, and 12 months post-surgery for radiographic and CBCT assessments

Trial Site Locations

Total: 1 location

1

Praktika 1

Moscow, Russia, 127006

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Research Team

A

Anton Sculean, Prof.

V

Vitaly Fuog, DMD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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