| CTRI Number |
CTRI/2025/02/081323 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
FULL PULPOTOMY IN MATURE PERMANENT TEETH WITH IRREVERSIBLE PULPITIS: A STUDY USING TWO BIOACTIVE MATERIALS |
|
Scientific Title of Study
|
FULL PULPOTOMY USING TWO BIOACTIVE MATERIALS IN MATURE PERMANENT TEETH DIAGNOSED WITH SYMPTOMATIC IRREVERSIBLE PULPITIS: 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 |
Ambika Bhardwaj |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BHOJIA DENTAL COLLEGE AND HOSPITAL |
| Address |
BHOJIA DENTAL COLLEGE AND HOSPITAL BHUD BADDI
BHUD, BADDI
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
8219493949 |
| Fax |
|
| Email |
ambikabhardwaj1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMITA |
| Designation |
PROFESSOR |
| Affiliation |
BHOJIA DENTAL COLLEGE AND HOSPITAL BHUD |
| Address |
BHOJIA DENTAL COLLEGE AND HOSPITAL
BADDI
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9878027370 |
| Fax |
|
| Email |
amitapsk2002@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ambika Bhardwaj |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BHOJIA DENTAL COLLEGE AND HOSPITAL BHUD |
| Address |
BHOJIA DENTAL COLLEGE AND HOSPITAL
BADDI
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
08219493949 |
| Fax |
|
| Email |
ambikabhardwaj1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHOJIA DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
BHOJIA DENTAL COLLEGE AND HOSPITAL BADDI |
| Address |
BHOJIA DENTAL COLLEGE AND HOSPITAL BHUD BADDI
|
| 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 |
| AMBIKA BHARDWAJ |
BHOJIA DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
ROOM NUMBER 7
IN BHOJIA DENTAL COLLEGE AND HOSPITAL BHUD BADDI
Solan
HIMACHAL PRADESH |
8219493949
ambikabhardwaj1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FULL PULPOTOMY USING TWO BIOACTIVE MATERIALS IN MATURE PERMANENT TEETH DIAGNOSED WITH SYMPTOMATIC IRREVERSIBLE PULPITIS |
The oral cavity will be rinsed with 0.2% chlorhexidine solution for 30 sec to minimize microbial contamination. Local anaesthesia will be administered using 2% lidocaine with 1:80000 adrenaline concentration to achieve profound pulpal anaesthesia. Upon achieving pulpal anaesthesia isolation of the tooth will be done with a rubber dam and all sides will be sealed with a liquid dam to ensure a contamination-free operative field.
Caries removal will be done using high speed sterile number-2 round bur under water coolant. For cases with missing tooth walls, restoration of the wall will be first accomplished using a matrix system and composite resin prior to the pulp exposure to aid in isolation. Deepest layers of carious dentin will be disinfected with 3% of sodium hypochlorite prior to pulp exposure. Complete pulp deroofing will be done and exposed pulp tissue will be removed with new sterile round bur till the orifices and haemostasis will be achieved by placing a moist cotton pellet soaked in 3 % Sodium Hypochlorite over the pulp for 5 minutes, if the bleeding persists moist cotton will again be placed for another 5 minutes to achieve haemostasis. After 10 minutes if bleed continue case will not be eligible for the study and RCT will be considered. After achieving haemostasis, the pulpotomy material will be prepared according to manufactured instruction and pulpotomy material ie either MTAputty or Theracal -PT will be placed on pulpal floor at a thickness of 2-3mm thereafter sealed with light cured GIC followed by composite as final restoration Material.
|
| Intervention |
Two interventional groups are present ie.Theracal PT group and MTA Putty group |
The oral cavity will be rinsed with 0.2% chlorhexidine solution for 30 sec to minimize microbial contamination. Local anaesthesia will be administered using 2% lidocaine with 1:80000 adrenaline concentration to achieve profound pulpal anaesthesia. Upon achieving pulpal anaesthesia isolation of the tooth will be done with a rubber dam and all sides will be sealed with a liquid dam to ensure a contamination-free operative field. Caries removal will be done using high speed sterile number-2 round bur under water coolant. For cases with missing tooth walls, restoration of the wall will be first accomplished using a matrix system and composite resin prior to the pulp exposure to aid in isolation. Deepest layers of carious dentin will be disinfected with 3% of sodium hypochlorite prior to pulp exposure. Complete pulp deroofing will be done and exposed pulp tissue will be removed with new sterile round bur till the orifices and haemostasis will be achieved by placing a moist cotton pellet soaked in 3 % Sodium Hypochlorite over the pulp for 5 minutes, if the bleeding persists moist cotton will again be placed for another 5 minutes to achieve haemostasis. After 10 minutes if bleed continue case will not be eligible for the study and RCT will be considered. After achieving haemostasis, the pulpotomy material will be prepared according to manufactured instruction and pulpotomy material ie either MTAputty or Theracal -PT will be placed on pulpal floor at a thickness of 2-3mm thereafter sealed with light cured GIC followed by composite as final restoration Material. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Teeth with symptomatic irreversible pulpitis with (spontaneous, lingering pain response to cold or electric pulp testing, nocturnal pain that can be mild to moderate.)
2.Medically healthy patients range between 18- 65 years of age
3.Restorable tooth with probing pocket depth and mobility within normal limits.
4.Extremely deep caries extending to pulp chamber
5.Patients who agree to written informed consent
6.Periapical index PAI score 1
|
|
| ExclusionCriteria |
| Details |
1.Immature teeth
2.Teeth with apical resorption
3.No signs and symptoms of irreversible pulpitis
4.Non restorable teeth
5.Uncontrollable bleeding following pulpotomy lasting more than 10 min.
6.Insufficient bleeding due to necrosis
7.Presence of sinus tract or swelling
8.Allergy to local anesthetic
9.Patients on analgesics, anti-inflammatory drugs & antibiotics
10.PAI score >1
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective will be to evaluate the effectiveness of two materials as pulpotomy agents in mature permanent teeth and compare the success rate of these materials in terms of clinical and radiographic evaluation at 12 month follow up. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective will be to evaluate reduction of preoperative pain after pulpotomy & whether any difference observed between the materials tested. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="68"
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)
|
01/04/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
This is a randomized, doble blind, parallel group prospective study in which we are comparing the efficacy of two pulpotomy materials i.e. TheraCal PT and MTA PUTTY for mature permanent teeth diagnosed with symptomatic irreversible pulpitis. Pain assessment will be done in recall examination at 24-hour, 48-hour and1 week postoperatively after initial appointment by using heft parker scale. If patient comes with pain after 7 days, then that case will be considered as an immediate failure in the study. Routine clinical and radiographic examination will be done at 3 months, 6 months and 12 months. Data will be statistically analysed. |