Healing and Patient Related OutcomesMicrosurgeryNCT07353580
Selective Curettage and Tissue Adhesive in Endodontic Microsurgery
A study testing Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive and Complete Periapical Lesion Curettage and Suturing in people with Healing and Patient Related Outcomes, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healing and Patient Related Outcomes
- What is being tested?
- Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive and Complete Periapical Lesion Curettage and Suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2024to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Conditions
- Healing and Patient Related Outcomes
- Being tested
- Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive, Complete Periapical Lesion Curettage and Suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Lesion Curettage and Cyanoacrylate Tissue AdhesiveProcedure or surgery
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 .
Complete Periapical Lesion Curettage and SuturingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Complete Periapical Lesion Curettage and Suturing | Active comparator | patients underwent conventional endodontic microsurgery with complete removal of the periapical lesion followed by flap repositioning and closure using sutures. Receives: Procedure: Complete Periapical Lesion Curettage and Suturing |
| Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive | Experimental | 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. Receives: Procedure: Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity is assessed using the Visual Analogue Scale (VAS, 0-10)
Measured: (1st, 3rd, and 7th day post-operative)
Swelling
Presence of swelling is assessed clinically by visual inspection and physical examination and recorded as a binary outcome (present / absent)
Measured: 1st, 3rd, and 7th day post-operative
Secondary outcomes (2)
Bleeding
Post-operative bleeding presence is assessed as a binary outcome (Yes / No)
Measured: 1st, 3rd, and 7th day post-operative
Radiographic Bone healing
Radiographic bone healing is assessed using standardized periapical radiographs (2D) and cone beam computed tomography (CBCT, 3D)
Measured: 3, 6 , and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 Dec 2024
- Primary completion29 Jan 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healing and Patient Related OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel El-Dreny Mohamed, Mansoura University
- Investigators
- Mohamed A El-dreny, Assis.Lec, Principal investigator, Faculty of Dentistry , Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353580
- Sponsor's protocol ID
- A02010024 RC
- Acronym
- Microsurgery
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nesari R, Kratchman S, Saad M, Kohli MR. Selective Curettage: A Conservative Microsurgical Approach to Treating Large and Complicated Lesions. J Endod. 2020 Nov;46(11):1782-1790. doi: 10.1016/j.joen.2020.07.023. Epub 2020 Jul 29.
PubMed 32738339
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Selective Curettage and Tissue Adhesive on the Clinical Outcomes of Endodontic Microsurgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07353580
- Acronym / sponsor ID
- Microsurgery / A02010024 RC
- Conditions
- Healing and Patient Related Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Periapical Lesion Curettage and Suturing | Active comparator | Procedure: Complete Periapical Lesion Curettage and Suturingpatients underwent conventional endodontic microsurgery with complete removal of the periapical lesion followed by flap repositioning and closure using sutures. |
| Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive | Experimental | Procedure: Selective Lesion Curettage and Cyanoacrylate Tissue AdhesivePatients underwent endodontic microsurgery with selective removal of approximately 40-70% of the periapical lesion, followed by flap closure using cyanoacrylate tissue adhesive without sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Lesion Curettage and Cyanoacrylate Tissue AdhesiveSelective 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 . | Procedure or surgery | Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive |
| Complete Periapical Lesion Curettage and SuturingComplete 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. | Procedure or surgery | Complete Periapical Lesion Curettage and Suturing |
Primary outcome
Pain intensity
Time frame: (1st, 3rd, and 7th day post-operative)
Pain intensity is assessed using the Visual Analogue Scale (VAS, 0-10)
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)
2 secondary outcomes
Bleeding
Time frame: 1st, 3rd, and 7th day post-operative
Radiographic Bone healing
Time frame: 3, 6 , and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 32738339Nesari R, Kratchman S, Saad M, Kohli MR. Selective Curettage: A Conservative Microsurgical Approach to Treating Large and Complicated Lesions. J Endod. 2020 Nov;46(11):1782-1790. doi: 10.1016/j.joen.2020.07.023. Epub 2020 Jul 29.
- Individual participant dataSharing planned: No
Related trials for Healing and Patient Related Outcomes
Not yet recruiting
MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation
Gingival Hyperpigmentation, Oral Health-Related Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A El-dreny, Assis.Lec principal investigator
Faculty of Dentistry , Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Lesion Curettage and Cyanoacrylate Tissue Adhesive and Complete Periapical Lesion Curettage and Suturing in people with Healing and Patient Related Outcomes, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: (1st, 3rd, and 7th day post-operative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07353580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.