| CTRI Number |
CTRI/2025/04/084202 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Results of Single versus Multi Visit Non Surgical Root Canal Treatment for Teeth with Chronic Apical Abscess Using CBCT to Assess the Outcomes |
|
Scientific Title of Study
|
Comparative CBCT Based Outcome of Single and Multi Visit Non Surgical Endodontic Therapy Performed in Teeth with Chronic Apical Abscess A Randomized Clinical 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 |
Debalina Dasgupta |
| Designation |
Junior Resident |
| Affiliation |
Student |
| Address |
Conservative Dentistry and Endodontics Centre for Dental Education and Research AIIMS Delhi
Conservative Dentistry and Endodontics Centre for Dental Education and Research AIIMS Delhi
South
DELHI
110029
India |
| Phone |
9089394471 |
| Fax |
|
| Email |
debalina124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Logani |
| Designation |
Head of the Department |
| Affiliation |
Center for Dental Education and Research AIIMS - New Delhi |
| Address |
Room no 313 Department of Conservative Dentistry and
Endodontics third floor Center for Dental Education and Research
AIIMS New Delhi
Room no 313 Department of Conservative Dentistry and
Endodontics third floor Center for Dental Education and Research
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9818936926 |
| Fax |
|
| Email |
apexlogani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Logani |
| Designation |
Head of the Department |
| Affiliation |
Center for Dental Education and research AIIMS - New Delhi |
| Address |
Room no 313 Department of Conservative Dentistry and
Endodontics third floor Center for Dental Education and Research
AIIMS New Delhi
Room no 313 Department of Conservative Dentistry and
Endodontics third floor Center for Dental Education and Research
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9818936926 |
| Fax |
|
| Email |
apexlogani@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics Center for Dental Education and
research All India Institute of Medical Sciences New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Debalina Dasgupta |
| Address |
Department of Conservative Dentistry and Endodontics Center 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 |
| Debalina Dasgupta |
Centre for Dental Education and Research All India Institute of Medical Sciences New Delhi |
Division of
Conservative Dentistry
and Endodontics
Centre for Dental
Education and
Research All India
Institute of Medical
Sciences New Delhi
110029
South DELHI
South
DELHI |
09089394471
debalina124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K046||Periapical abscess with sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi (two) visit non surgical endodontic therapy |
Caries will be completely removed. Multi (two) visit non surgical endodontic therapy will be performed with placement of intracanal medicaments (calcium hydroxide). |
| Comparator Agent |
single visit non surgical endodontic therapy |
Caries will be completely removed. Single visit non surgical endodontic therapy will be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Posterior maxillary & mandibular teeth with chronic apical abscess that is with a presence of intra oral sinus tract
Radiographic evidence of established radiolucent lesion
Teeth should be restorable
Either gender belonging to 18 to 65 years of age group
Teeth with necrotic pulp confirmed by pulp test
Patients without significant systemic disease |
|
| ExclusionCriteria |
| Details |
Intra oral sinus in attached gingiva that is Suggestive of vertical root fracture
Teeth without associated intra oral sinus tract
Teeth with fracture, subgingival caries and poor periodontal health
Patients with systemic conditions which could compromise the healing
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 |
To evaluate the Clinical and Radiographic Outcome in Teeth with Chronic Apical Abscess Treated in:
a. Single visit non surgical endodontic therapy
b. Multi (two) visit non surgical endodontic therapy |
6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To establish the prevelance of teeth with chronic apical abscess
b. To establish the position of intraoral draining sinus in teeth with chronic apical abscess (buccal or lingual or palatal), Site of sinus, number of sinus, status of sinus (active drainage versus no drainage) |
7, 14 and 21 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
09/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Chronic apical abscess is an inflammatory response to pulpal infection and necrosis, typically charaterized by a gradual onset, minimal or absent discomfort and an intermittent dischargevof pus through an associated sinus tract, Radiographically, this abscess often present with signs of osseous destruction, such as a radiolucency.According to Sathorn et al. in 2005, approximately 70% of endodontist treat these cases with single visit non surgical endodontic therapy. Single visit non surgical endodontic therapy gained popularity due to several advantaged including reduced flare up, convenience, improved patient acceptance and better practice management (Walton & Fouad, 1992; Imura & Zuolo 1995). However, teeth with chronic apical abscess and sinus tract exhibit a complex infectious pattern in the apical root canal sysytem and periapical lesion, often involving biofilms (Ricucci D, 2018). Mechanical debridement combined with antibacterial regimen using 0.5% sodium hypochlorite has been shown to render 40-60% of treated teeth bacteria negative (Bystrom & Sjogren et al. 1997). A recent retrospective study by Artaza et al in 2021 reported a success rate of 79.3% for single visit treatment of cases with sinus tract, indicating that 2 out of 10 cases has failed. The present of sinus tract in a tooth with long standing infection can negatively influence the resolution of apical periodontitis, thereby increasing the likelihood of treatment failure. Moreover, in chronic cases, due to the deeper penetration of microbiota into the root canal, effective disinfection cannot be achieved in a single visit. Additionally, dressing the canal with calcium hydroxide for one week can increase the percentage of bacteria free teeth to approximately 70% (Law & Messer, 2004). Given that this regimen further reduces bacterial load, it can be hypothesized that multiple visit treatment, incorporating calcium hydroxide dressing between appointments, may yield higher healing rates compared to single visit treatment without calcium hydroxide dressing in teeth with chronic apical abscess. Therefore, to solve the dilemma for management strategy for chronic apical abscess there is a compelling need for well designed clinical trials to evaluate whether it should be treated with single or multi (two) visit. The impact of single or multi (two) visit non surgical endodontic therapy using Cone Beam Computed Tomography (CBCT) in cases of chronic apical abscess has not been studied previously in the literature. Hence, this study aims to conduct a Randomized Clinical Trial (RCT) following CONSORT guidelines, evaluating the CBCT based outcome of single and multi (two) non surgical endodontic therapy performed in teeth with chronic apical abscess.
|