Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07501585 for Periapical Periodontitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
University of BernHyaluronic Acid in Endodontic Microsurgery 46 Randomized
Clinical Trial NCT07501585 is an interventional study for Periapical Periodontitis that is recruiting. It started on 20 February 2026 with plans to enroll 46 participants. Led by University of Bern, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
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...Show More
Detailed Description
Background and Rationale:
Endodontic microsurgery is an established treatment for persistent apical periodontitis after non-surgical root canal treatment. Successful healing depends on appropriate surgical technique, infection control, and favorable soft and hard tissue regeneration. Cross-linked hyaluronic acid is a non-animal-origin biomaterial with hydrating, tissue-supportive, and bacteriostatic properties, and ...
Show MoreOfficial Title
Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT
Conditions
Periapical PeriodontitisOther Study IDs
- HA in endo surgery
NCT ID Number
Start Date (Actual)
2026-02-20
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
46
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Endodontic microsurgery
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTest: endodontic microsurgery with hyaluronic acid The endodontic microsurgery will be performed, then cross-linked hyaluronic acid will be added in the surgical area. | Hyaluronic 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...Show More Endodontic 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...Show More |
Active ComparatorControl: mere endodontic microsurgery Endodontic microsurgery will be performed only. | Endodontic 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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | within the two first weeks after surgery |
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. | 3, 6, and 12 months post-surgery |
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. | 6 and 12 months post-surgery |
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 | 6 and 12 months post-surgery |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
University of Bern178 active studies to exploreStudy Central Contact
Contact: Anton Sculean, Prof., +41316840620, [email protected]
Contact: Vitaly Fuog, DMD, +41795378238, [email protected]
1 Study Locations in 1 Countries
Praktika 1, Moscow, 127006, Russia
Anton Sculean, Prof, Contact, +41316840620, [email protected]
Alexandra Stähli, PD, Contact, +41316840620, [email protected]
Recruiting