Hyaluronic Acid in Endodontic Microsurgery

NCT07501585 | Recruiting

• 1 other identifier: HA in endo surgery
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial (RCT) will evaluate the effectiveness of cross-linked hyaluronic acid as an adjunct to endodontic microsurgery in adult patients with apical periodontitis affecting maxillary or mandibular first molars. Participants previously treated with non-surgical endodontic therapy will be allocated to either endodontic microsurgery with cross-linked hyaluronic acid application (test group) or the same surgical procedure without adjunctive material (control group), with 12 months of follow-up. The study hypothesis is that cross-linked hyaluronic acid improves soft- and hard-tissue healing, reduces postoperative inflammation and pain, and supports more stable surgical outcomes. Primary outcomes include early soft tissue healing (Early Wound Healing Score, day 4) and postoperative pain (visual analogue scale). Secondary outcomes include periapical healing assessed by blinded evaluators on periapical radiographs (Molven criteria) at 3, 6, and 12 months, and on CBCT scans (PENN 3D criteria) at 6 and 12 months, as well as cortical plate healing (RAC/B index). This study aims to provide clinical evidence on the potential regenerative and anti-inflammatory benefits of cross-linked hyaluronic acid in endodontic microsurgery.

Conditions

Periapical Periodontitis

Keywords

Endodontic microsurgery

Outcome Measures

Primary Outcomes (1)

• The healing of soft tissues will be evaluated by the Early wound healing score

  The early wound healing index assesses periodontal soft tissue healing, usually around 1 week post-surgery, by evaluating flap closure, fibrin presence, and necrosis in 5 grades. It ranges from score 1 (complete healing) to score 5 (necrosis and pus)

  4 days after surgery

Secondary Outcomes (4)

• The postoperative pain will be evaluated by visual analogue scale VAS

  within the two first weeks after surgery

• Periapical healing assessed on periapical radiographs according to the Molven's criteria

  3, 6, and 12 months post-surgery

• Pericapial healing on cone beam computed tomography (CBCT) scans according to PENN's criteria

  6 and 12 months post-surgery

• Cortical plate healing

  6 and 12 months post-surgery

Study Arms (2)

Test: endodontic microsurgery with hyaluronic acid

EXPERIMENTAL

The endodontic microsurgery will be performed, then cross-linked hyaluronic acid will be added in the surgical area.

Procedure: Hyaluronic Acid; Procedure: Endodontic microsurgery

Control: mere endodontic microsurgery

ACTIVE COMPARATOR

Endodontic microsurgery will be performed only.

Procedure: Endodontic microsurgery

Interventions

Hyaluronic Acid PROCEDURE

The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, application of cross-linked hyaluronic acid through the cannula into the osteotomy, until the bone defect is completely filled and under the flap, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene).

Test: endodontic microsurgery with hyaluronic acid

Endodontic microsurgery PROCEDURE

The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene).

Control: mere endodontic microsurgery; Test: endodontic microsurgery with hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Praktika 1

Moscow, 127006, Russia

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Anton Sculean, Prof.

  University of Bern

  STUDY CHAIR

Central Study Contacts

Anton Sculean, Prof.

CONTACT

+41316840620; anton.sculean@unibe.ch

Vitaly Fuog, DMD

CONTACT

+41795378238; vitaly.fuog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are in surgery not seeing the surgical intervention and not knowing if adjunctive HA will be applied. The outcome assessor is not involved in the patient allocation nor the surgical intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-armed, single-center, double-blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)