| CTRI Number |
CTRI/2025/01/079084 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Type 2 Diabetes mellitus on the outcome after removal of Portion of Living Tissue in Teeth with Symptoms of Irreversible Pulpal Infection: A Clinical Study |
|
Scientific Title of Study
|
Influence of Type 2 Diabetes Mellitus on the Outcome of Full Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Prospective study |
| 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 Jyoti Chauhan |
| Designation |
Junior Resident |
| Affiliation |
All India Insitute of Medical Sciences, New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics,3rd floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9927743534 |
| Fax |
|
| Email |
jychauhan05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Chawla |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 309, Division of Conservative Dentistry and Endodontics,3rd floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Chawla |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 309, Division of Conservative Dentistry and Endodontics,3rd floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, 3rd floor, Center for Dental Education and Research, AIIMS, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
Center for Dental Education and Research |
| Address |
Department of Conservative Dentistry and Endodontics, 3rd floor, Center for Dental Education and Research, AIIMS, New Delhi- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Chauhan |
Centre for Dental Education and Research |
Division of Conservative Dentistry and Endodontics, 3rd floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI |
9927743534
jychauhan05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, NEW DELHI-110029, Room no 102, 1st floor, Old O.T Block Tel No 4576 (Internal) 26594579 (Direct) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full Pulpotomy |
Removal of a part of pulp inside the tooth and replacing it with a calcium silicate based cement.
The procedure is done in 45-60 minutes |
| Comparator Agent |
Full Pulpotomy in Diabetic patients |
HbA1c level equal or greater then 6.5%, Removal of a part of pulp inside the tooth and replacing it with a calcium silicate-based cement. The procedure is done in 45-60 minutes |
| Comparator Agent |
Full Pulpotomy in non-diabetic patients |
HbA1c level less then 6.5%, Removal of a part of pulp inside the tooth and replacing it with a calcium silicate-based cement. The procedure is done in 45-60 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic Patients:-
1.Patients with a history of T2DM having HbA1c levels ≥ 6.5%
of either gender belonging to age range from 30 to 65
years.
2.Permanent mandibular first & second molars having carious
lesion diagnosed clinically and radiologically as
symptomatic irreversible pulpitis.
3.Teeth with positive response to electric pulp test and
cold test.
4.Radiographic examination showing periapical index score
(PAI) of 1 or 2.
5.Teeth with restorable carious lesions.
6.Periodontally sound teeth.
7.Absence of any signs of pulpal necrosis including swelling or sinus tract.
Non Diabetic Patients:-
1.Patients having HbA1c levels < 6.5% of either gender belonging to age range from 30 to 65
years.
2.Permanent mandibular first & second molars having carious
lesion diagnosed clinically and radiologically as
symptomatic irreversible pulpitis.
3.Teeth with positive response to electric pulp test and
cold test.
4.Radiographic examination showing periapical index score
(PAI) of 1 or 2.
5.Teeth with restorable carious lesions.
6.Periodontally sound teeth.
7.Absence of any signs of pulpal necrosis including swelling or sinus tract.
|
|
| ExclusionCriteria |
| Details |
Diabetic patients’ exclusion criteria-
1.Radiographic examination showing periapical
index score (PAI) of 3-5
2.Teeth with cracks, cusp fractures, subgingival
caries and poor periodontal health.
3.Patients with systemic conditions other than
diabetes mellitus, like hypertension, bleeding
disorders, asthma. and those required
steroids.
4.Pregnant patients.
5.Patients having history of smoking
6.Patients with a history of antibiotic intake
in the preceding month.
7.Teeth with immature roots.
8.Patients not willing to participate in the
study.
Nondiabetic patients’ exclusion criteria-
1.Radiographic examination showing periapical
index score (PAI) of 3-5
2.Teeth with cracks, cusp fractures, subgingival
caries and poor periodontal health
3.Patients with systemic conditions
4.Patients taking steroids.
5.Pregnant patients.
6.Patients having history of smoking.
7.Patients with a history of antibiotic intake
in the preceding month.
8.Teeth with immature roots.
9.Patients not willing to participate in the
study
Intraoperative exclusion criteria:
1.No pulp exposure seen after complete caries
excavation
2.Clinical diagnosis changes to pulpal necrosis
3.Bleeding that cannot be controlled within 5-
10 minutes with 2.5% NaOCl wet cotton pellet.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to evaluate the clinical and radiographic outcome of full pulpotomy performed in permanent mature mandibular molars indicative of symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients (HbA1c less then 6.5%) and compare them. |
6month and 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome
1. To evaluate the time taken to achieve hemostasis during full pulpotomy performed in permanent mandibular molars with symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients(HbA1c less then 6.5%) and compare them.
2. To evaluate the pulp sensibility test in Type 2 diabetes mellitus patients(HbA1c greater or equal then 6.5%) and non diabetic patients(HbA1c less then 6.5%) and compare them. |
During procedure, at 6 month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Teeth diagnosed with irreversible pulpitis are characterized by having spontaneous, intense and lingering pain (often lasting 30 seconds or more after stimulus removal) that is often triggered by thermal stimuli.The preferred treatment of choice in such a scenario will be conventional non- surgical endodontic treatment (NSET) which has a success rate of 95% with an excellent prognosis. In recent times, there has been a paradigm shift in treating teeth diagnosed with SIP with Vital Pulp Therapy (VPT). “Full pulpotomy refers to the complete removal of the coronal pulp and application of a biomaterial directly onto the pulp tissue at the level of the root canal orifice, prior to placement of a permanent restorationâ€. Taha NA et al 2018,2022 study, Cushley et.al, Jassal A et.al, Kumar V et al studies had a success rate of 83% to 98% full pulpotomy of symptomatic irreversible pulpitis teeth, all these studies had inclusion criteria of healthy individuals and exclusion of patients having any systemic disease. Type 2 diabetes mellitus (T2DM) is a global health concern characterized by insulin resistance and hyperglycemia.Type2 DM group exhibited a higher proportion of M1 macrophages. Various cytokines produced by M1 macrophages could be responsible for delayed wound healing. Diabetic patients may present with altered inflammatory responses and delayed healing as concluded in a prospective study conducted by Arya S et al (2017). The authors compared the success of primary root canal treatment between type 2 diabetic and nondiabetic patients and found that diabetes mellitus (DM) may have a negative impact on the outcome of endodontic treatment in terms of periapical healing.This also suggests that T2DM may have an effect on the outcomes of dental treatments like pulpotomy. While full pulpotomy has shown favorable outcomes in systemically healthy patients, it is crucial to assess whether similar results can be expected in patients with T2DM.There is a gap in the current literature on the outcomes of full pulpotomy specifically in patients with T2DM, and hence this study planned to conduct.
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