Hyaluronic Acid in Endodontic Microsurgery
ConditionPeriapical Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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%
Disqualifiers
Smokers of more than 10 cigarettes a day
Allergy to hyaluronic acid
Pregnancy or lactation
Uncontrolled Diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic Acid
Procedure/SurgeryThe 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).
Endodontic microsurgery
Procedure/SurgeryThe 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).
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Test: endodontic microsurgery with hyaluronic acidExperimental treatment 2 interventions
Group B: Control: mere endodontic microsurgeryActive comparator 1 intervention
Trial outcomes
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)
Time frame
4 days after surgerySecondary outcomes
1
The postoperative pain will be evaluated by visual analogue scale VAS
The visual analogue scale is a mm scale from 0 (no pain) to 100 mm (maximal possible pain)
Time frame
within the two first weeks after surgery2
Periapical healing assessed on periapical radiographs according to the Molven's criteria
The Molven's criteria is a 2D radiographic classification system used to evaluate the healing outcome of apical endodontic surgery, four main categories exist: Complete Healing: Bone tissue is completely restored, and a normal periodontal ligament (PDL) space is visible. Incomplete Healing (Scar Tissue): The initial radiolucent area has reduced in size, but a small residual rarefaction remains, often characterized as a "scar". Uncertain Healing: A reduction in the size of the lesion has occurred, but it does not fit the criteria for complete or incomplete healing. Unsatisfactory Healing (Failures): The radiolucent lesion is unchanged, has increased in size, or appears newly developed, indicating failure.
Time frame
3, 6, and 12 months post-surgery3
Pericapial healing on cone beam computed tomography (CBCT) scans according to PENN's criteria
Healing of endodontic microsurgery assessed using CBCT imaging, categories: Complete Healing (Success): Full bone repair, with the periodontal space having a normal width. Limited Healing (Success): Bone regeneration, but the periodontal space over the resected root surface is slightly widened (but less than twice the width of non-involved root). Uncertain Healing (Failure): A small defect or continued radiolucency persists in the lamina dura around the root-end filling. Unsatisfactory Healing (Failure): No change or an increase in the size of the radiolucent area, with poor bone repair.
Time frame
6 and 12 months post-surgery4
Cortical plate healing
Cortical plate healing will be scored according to the RAC/B index: Score 0: Cortical plate not re-established. Score 1: Cortical plate is partially re-established. Score 2: Cortical plate is re-established
Time frame
6 and 12 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov