- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353580
Selective Curettage and Tissue Adhesive in Endodontic Microsurgery (Microsurgery)
Impact of Selective Curettage and Tissue Adhesive on the Clinical Outcomes of Endodontic Microsurgery: A Randomized Controlled Trial
The goal of this randomized clinical trial is to determine whether selective curettage combined with cyanoacrylate tissue adhesive improves clinical outcomes in endodontic microsurgery compared with the conventional approach. The study purpose is to evaluate the postoperative healing associated with this conservative surgical protocol.
The main questions it aims to answer are:
Does selective curettage with tissue adhesive reduce postoperative pain, swelling, and complications compared to complete curettage with suturing?
How does selective curettage affect clinical and radiographic healing of persistent periapical lesions?
Researchers compared complete lesion curettage with suturing to selective curettage (40-70% lesion removal) with cyanoacrylate tissue adhesive closure to assess differences in healing and patient-related outcomes.
Participants :
Underwent endodontic microsurgery using one of the two surgical protocols Attended follow-up visits at 1, 3, and 7 days for clinical evaluation of pain, swelling ,Discomfort , Bleeding , Local reaction and Wound Dehiscence
Attended follow-up visits at 3, 6, and 12 months for clinical and radiographic evaluation of periapical healing using 2D radiographs and CBCT
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Al Mansurah, Egypt
- Faculty of Dentisrty , Mansoura University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative and at least 1 follow-up CBCT evaluation.
- Noncontributory medical history (American Society of Anesthesiologists class I, II).
- Teeth with periapical lesions that had been previously treated or retreated but symptoms persist or recurrent.
- Radiographic presence of true endodontic lesion close to vital critical structure.
Exclusion Criteria:
- Nonconsenting patients and patients younger than 18 years of age.
- Medical history with the American Society of Anesthesiologists class III to V.
- Insufficient coronal restoration.
- Nonrestorability or traumatized teeth.
- Mobility > 1.
- Vertical root fracture.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Complete Periapical Lesion Curettage and Suturing
patients underwent conventional endodontic microsurgery with complete removal of the periapical lesion followed by flap repositioning and closure using sutures.
|
Complete Periapical Lesion Curettage and Suturing is a conventional endodontic microsurgical procedure performed to manage persistent periapical pathology following root canal treatment.
After administration of local anesthesia, a full-thickness mucoperiosteal flap is elevated to expose the periapical region.
The periapical lesion is completely curetted and removed, followed by apical root-end resection.
A retrograde cavity is prepared using ultrasonic tips and sealed with a biocompatible root-end filling material.
Hemostasis is achieved, and the surgical flap is repositioned and stabilized using conventional sutures.
This approach represents the standard surgical protocol for endodontic microsurgery and serves as the active comparator in this study.
|
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Experimental: Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive
Patients underwent endodontic microsurgery with selective removal of approximately 40-70% of the periapical lesion, followed by flap closure using cyanoacrylate tissue adhesive without sutures.
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Selective curettage is a conservative approach to treat periapical lesions by removing part of the granulomatous tissue while avoiding complications and damage to the neighboring structures.
It also provides the least traumatic approach with minimal post-operative complications.
It had an additional advantage, which is providing tissue samples for biopsy of the lesion, especially in cases where there was a diagnostic dilemma regarding its origin .
In the selective curettage technique, approximately 50-70% of the granulomatous tissue was removed while preserving the portion in close proximity to critical areas, followed by standard root-end resection and retrofilling then Clinical and radiographic assessments, including CBCT, for bone healing assesment .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: (1st, 3rd, and 7th day post-operative)
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Pain intensity is assessed using the Visual Analogue Scale (VAS, 0-10)
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(1st, 3rd, and 7th day post-operative)
|
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Swelling
Time Frame: 1st, 3rd, and 7th day post-operative
|
Presence of swelling is assessed clinically by visual inspection and physical examination and recorded as a binary outcome (present / absent)
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1st, 3rd, and 7th day post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding
Time Frame: 1st, 3rd, and 7th day post-operative
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Post-operative bleeding presence is assessed as a binary outcome (Yes / No)
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1st, 3rd, and 7th day post-operative
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Radiographic Bone healing
Time Frame: 3, 6 , and 12 months
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Radiographic bone healing is assessed using standardized periapical radiographs (2D) and cone beam computed tomography (CBCT, 3D)
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3, 6 , and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A El-dreny, Assis.Lec, Faculty of dentistry , Mansoura university
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A02010024 RC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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