RecruitingNot ApplicableNCT07501585

Hyaluronic Acid in Endodontic Microsurgery

Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT

Sponsor

University of Bern

Enrollment

46 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

Periapical Periodontitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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

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Interventions

PROCEDUREHyaluronic Acid

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).

PROCEDUREEndodontic microsurgery

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).