| CTRI Number |
CTRI/2025/09/094656 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare complete and incomplete removal of infectious tissue in Large cyst-like lesions involving root tips during Endodontic Microsurgery in anterior teeth. |
|
Scientific Title of Study
|
Surgical Outcome of Selective or Complete Curettage Performed in Large Cyst-like Periapical Lesions of Endodontic Origin: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saiyada Laiba |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
| Address |
Division of Conservative Dentistry and Endodontics, third floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi DELHI 110029 India |
| Phone |
9897647615 |
| Fax |
|
| Email |
saiyada.laiba.fatima@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sidhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
| Address |
Division of Conservative Dentistry and Endodontics, third floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi DELHI 110029 India |
| Phone |
958254655 |
| Fax |
|
| Email |
sid.aiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sidhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
| Address |
Division of Conservative Dentistry and Endodontics, third floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi DELHI 110029 India |
| Phone |
958254655 |
| Fax |
|
| Email |
sid.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Dr Saiyada Laiba |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saiyada Laiba |
Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029 New Delhi DELHI |
9897647615
saiyada.laiba.fatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K045||Chronic apical periodontitis, (4) ICD-10 Condition: K048||Radicular cyst, (5) ICD-10 Condition: K046||Periapical abscess with sinus, (6) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Complete Curettage |
Two visit Nonsurgical Root Canal Therapy will be performed. Periapical surgery will be performed after 7 days in which complete curettage of the lesion will be performed followed by removal of 3 mm of the infected root apex and retrograde filling of calcium silicate based cement. |
| Intervention |
Selective curettage |
Two visit Nonsurgical Root Canal Therapy will be performed. Periapical surgery will be performed after 7 days in which selective curettage of the lesion will be performed followed by removal of 3 mm of the infected root apex and retrograde filling of calcium silicate based cement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asian healthy (ASA I) subjects of either gender between 18 and 60 years of age.
Radiographically diagnosed with a large cyst-like periapical lesion larger than 10mm associated with non-vital permanent anterior teeth.
Acceptable periodontal status (probing depth less than 4mm) |
|
| ExclusionCriteria |
| Details |
a) Patients with inadequate oral hygiene or periodontal health.
b)Patients with systemic conditions that could compromise the
healing.
c)Pregnant or lactating women.
d)History of previous periapical surgery on the same tooth.
e)Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the surgical outcome of selective curettage performed in large- cyst like periapical lesions of endodontic origin in permanent anterior teeth.
2. To evaluate the surgical outcome of complete curettage performed in large- cyst like periapical lesions of endodontic origin in permanent anterior teeth.
3. To compare the above.
|
6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the postoperative pain, swelling, analgesics needed, and patient-reported quality of life (OHRQoL) for selective curettage performed in large-cyst like periapical lesions of endodontic origin in permanent anterior teeth.
2. To evaluate the postoperative pain, swelling, analgesics needed, and patient-reported quality of life (OHRQoL) for complete curettage performed in large-cyst like periapical lesions of endodontic origin in permanent anterior teeth.
3. To compare the above. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periapical lesions of endodontic origin are primarily caused by persistent microbial infection within the root canal system. These lesions represent the body’s immunological response to irritants from the necrotic pulp and are typically managed by nonsurgical root canal therapy (RCT), which aims to eliminate the source of infection and promote periapical healing. In most cases, particularly those with lesions of limited size, this approach is sufficient. However, large cyst like periapical lesions (LCPLs) defined by radiographic dimensions exceeding 10 mm or areas greater than 200 mm2 pose a clinical challenge. These lesions are often aspirated as straw colored fluid, are associated with long-standing chronic infections, and may be suggestive of radicular cysts or pocket cysts. However, the definitive diagnosis can only be established after histological evaluation. Although many LCPLs may resolve with proper endodontic disinfection alone, persistent or symptomatic cases often require surgical intervention. Endodontic microsurgery (EMS), utilizing magnification and microsurgical instruments, is now considered the standard of care for such lesions when nonsurgical options fail. A meta-analysis demonstrated a pooled success rate of 94 percent for endodontic microsurgery (EMS), with a 95 percent confidence interval ranging from 0.8889 to 0.9816, based on a minimum follow-up duration of 12 months (Setzer et al 2012). Furthermore, long-term follow-up extending beyond six years indicated a sustained success rate of 93.3 percent (Song et al. 2012). During EMS, periapical curettage or enucleation is routinely performed to remove the pathological tissue from the periapical area. Traditional protocols favour complete removal of the lesion, aiming to eliminate all epithelial and granulation tissue, which could otherwise act as a nidus for recurrence if the lesion is self-sustaining. Further, complete degranulating the tissue provides adequate haemostasis, making the surgical procedure more efficient. However, this practice is not without limitations. Complete removal may be challenging or risky in lesions that extend close to critical anatomical structures such as the adjacent teeth, nasal floor, maxillary sinus, mental foramen, or neurovascular bundles. In LCPLs, selective curettage can serve as a conservative surgical technique, involving the removal of about 50 percent to 70 percent of the lesion tissue. This approach is intended to conserve nearby healthy tissues and protect vital anatomical structures. Historically, decompression or tubing method has been advocated for extensive lesions in proximity to vital structures,. Several hypotheses have been proposed regarding the mechanisms by which decompression facilitates healing. It enables continuous drainage, which is essential for initiating the reparative process, and may also mitigate the development of hyperosmotic pressure within the lesion. Furthermore, the inflammatory response induced by the procedure may contribute to the disruption of the cystic epithelial lining, promoting lesion resolution. Despite its benefits, decompression is associated with several limitations, including the need for frequent postoperative adjustments, inflammation of the alveolar mucosa, persistence of the surgical defect at the insertion site, potential for acute or chronic infection, submergence of the drainage tube into surrounding tissue, patient noncompliance, and challenges in obtaining biopsy specimens. In light of these limitations, Natkin et al. (1984) proposed an alternative approach involving partial removal of the cystic lining. This technique involves intentional rupture of the cystic sac with limited tissue removal, thereby minimizing trauma to vital root apices and adjacent anatomical structures while still permitting adequate drainage and potential disruption of the cyst lining to facilitate healing. The pattern of healing observed may resemble the spontaneous resolution of large cyst-like periapical lesions (LCPLs) following extraction, without surgical enucleation. Wong et al. subsequently supported this technique in a case series, referring to it as “surgical fenestration.” This method was noted to preserve the principal advantage of decompression protection of adjacent vital structures while offering additional benefits, such as feasibility of biopsy and improved patient compliance. In the only prospective clinical study to date, Shah et al. compared surgical fenestration to complete enucleation in histopathologically confirmed radicular cysts during conventional endodontic surgery and reported comparable healing outcomes. Furthermore, surgical fenestration was found to be technically simpler, less time-consuming, and less invasive. More recently, Nesari et al. and Li et al. reported case series in which selective curettage, rather than complete removal, was employed for the management of large periapical lesions subsequently diagnosed as periapical granulomas or cysts. Follow up assessments using both two-dimensional and three-dimensional imaging modalities demonstrated satisfactory healing in all cases. These emerging lines of evidence underscore a clinically significant question: Is complete surgical enucleation indispensable for optimal healing of large periapical lesions, or can conservative interventions such as selective curettage yield equivalent therapeutic outcomes. To date, no study has directly compared the outcomes of selective versus complete curettage in the context of modern endodontic microsurgery. This randomized controlled trial is designed to evaluate and compare both clinician and patient centred outcomes of selective and complete curettage approaches for the management of large cyst like periapical lesions during endodontic microsurgery. |