| CTRI Number |
CTRI/2024/02/062482 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Healing outcomes of pulpotomy compared with root canal treatment in patients diagnosed with symptomatic irreversible pulpitis: A randomized controlled trial |
|
Scientific Title of Study
|
Effect of healing outcomes of pulpotomy compared with root canal treatment in
patients diagnosed with symptomatic irreversible pulpitis: 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 |
Dr Sumanthini M V |
| Designation |
Head of Department |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Department of Conservative Dentistry and Endodontics, floor no-2, PG Clinics,
Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe, Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9869433642 |
| Fax |
|
| Email |
margsuman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumanthini M V |
| Designation |
Head of Department |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Floor no-2, PG clinics,
Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9869433642 |
| Fax |
|
| Email |
margsuman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumanthini M V |
| Designation |
Head of Department |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Floor No-2, PG clinics,
Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9869433642 |
| Fax |
|
| Email |
margsuman@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Floor No-2, PG clinics,
Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe Navi Mumbai, Maharashtra |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital |
| Address |
Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe Navi Mumbai, Maharashtra 410209 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Sumanthini M V |
MGM Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Floor no-2, PG clinics, Junction of NH4 and, Sion - Panvel Hwy, Sector 1, Kamothe Navi Mumbai, Maharashtra 410209
Mumbai
MAHARASHTRA |
9869433642
margsuman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Missions Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
symptomatic irreversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulpotomy |
After anesthesia, rubber dam isolation coronal access will be made by sterile round diamond point. The coronal pulp tissue will be excised using a spoon excavator until the canal orifice. To achieve hemostasis, a sterile cotton pellet soaked in 5% NaOCl will be placed for 30 seconds after extensive rinsing of the cavity with normal saline. The pulpal wound will then be covered with a minimum 2-mm-thick layer of ProRoot MTA. GIC will be placed as a base over MTA and the remaining cavity will be restored with composite restoration. Occlusal adjustments of restorations will be done, finished, and polished. |
| Comparator Agent |
Root canal treatment |
Following access cavity preparation and establishment of apical patency, root canals of will be cleaned and shaped using crown down technique. The canal will be fully irrigated after cleaning and shaping and master cone will be chosen in accordance with master apical file. By using a cold lateral compaction obturation technique, the canals will be sealed off using gutta-percha points. Post obturation restoration will be done by placing GIC as base followed by composite restoration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients who accept goals and requirements and are willing to participate in study.
All patients are in good health, based on their written histories and oral interviews.
Patients with moderate to severe pain involving one tooth.
Vital teeth with irreversible pulpitis with or without apical periodontitis.
Patients with PAI index score of 1
Thermal and electric pulp test yielded a positive response.
teeth with favorable condition for rubber dam isolation.
Teeth with fully developed apex.
Teeth with healthy periodontium with periodontal probing depth less than 3 mm.
Permanent human teeth.
Intact teeth with no cracks or defects.
Roots with patent canals. |
|
| ExclusionCriteria |
| Details |
Patients who will not accept the study freely.
Patients who do not provide authorization for participation.
Patients below 18 years and above 50 years of age.
Pregnant women and nursing mothers.
Patients with non-vital teeth
Patients with acute or chronic dentoalveolar abscess or cellulitis.
Patients whose tooth has been accessed previously or endodontically treated.
Patients with inflamed pulp in which bleeding could not be controlled within 10 minutes.
Patients who have taken medications which, in the opinion of the investigator, could interfere with the conduct of the study (example corticosteroids, antibiotics and analgesics in the past month).
Patients with known systemic disorders or immunocompromised conditions (example diabetes, AIDS)
Patients with PAI index score greater than 1
Patients with an intraoral and extraoral sinus tract.
Patients who are having teeth with multiple canals, bifurcation and trifurcation of canals, canal aberration, calcified canals, open apex, root resorption, presence of root caries and multirooted teeth.
Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth greater than 3mm.
Severe labially or lingually malposition teeth in which obtaining straight-line access will be difficult.
Teeth are indicated for intentional endodontic therapy for prosthetic reasons. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| healing outcomes measured in terms of pain |
6, 24 hours, 7 days, 3, 6, 9, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical outcomes in terms of signs and symptoms |
6, 24 hours, 7 days, 3, 6, 9, 12 months |
| radiographic outcome in terms of periapical index score |
6, 24 hours, 7 days, 3, 6, 9, 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rohitpmagar@gmail.com].
- For how long will this data be available start date provided 15-02-2024 and end date provided 14-02-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The most common oral health issue is untreated dental caries in permanent teeth. Dental caries left untreated can result in the spread of bacteria and their toxins entering the dental pulp, inflaming it to varied degrees. In previous studies it has been observed that the underlying pulp continued to be free of inflammation even in advanced cases of inflammation with irreversible pulpitis, with only isolated portions of pulp in the coronal aspect experiencing bacterial invasion and micro abscesses. After excavation of infected coronal pulp tissue followed by restoration with biomimetic materials like MTA may prevent the further progress of infection. Thus, the vitality of the radicular pulp can be maintained. The Purpose of the current randomized controlled trial will be to assess the healing outcomes clinically and radiographically in adult patients diagnosed with symptomatic irreversible pulpitis. This is a prospective single blind (observer blind) open label trial. The post-operative pain levels and healing outcomes between Pulpotomy and RCT group will be assessed at baseline, 6 hours, 24 hours and 7 days post-operative time intervals and the data will be statistically analyzed using unpaired t-test (for parametric data) or Mann-Whitney U test (for non-parametric). Within group comparison for the post-operative pain levels between Pulpotomy and RCT group will be assessed at baseline, 6 hours, 24 hours and 7 days post- operative time intervals using repeated measure ANOVA and Tukey’s post-hoc (for parametric data) or Kruskal–Wallis ANOVA and Dunn’s post-hoc (for non-parametric).
|