| CTRI Number |
CTRI/2024/10/074909 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare conventional endodontic treatment and vital pulp therapy with the combined approach |
|
Scientific Title of Study
|
A comparative evaluation of regenerative endodontic therapy, vital pulp therapy and combination of regenerative endodontic and vital pulp therapy in permanent mature mandibular molar teeth with periapical lesions. |
| 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 Neelam Mittal |
| Designation |
Professor |
| Affiliation |
Faculty of dental sciences,IMS,BHU |
| Address |
Room no.6,3rd floor, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,IMS,BHU,Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415203360 |
| Fax |
|
| Email |
drneelamittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chanda dhakad |
| Designation |
Junior resident |
| Affiliation |
Faculty of dental sciences,IMS,BHU |
| Address |
Room no.6,3rd floor, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,IMS,BHU,Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08290219041 |
| Fax |
|
| Email |
chandadhakad002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chanda dhakad |
| Designation |
Junior Resident |
| Affiliation |
Faculty of dental sciences,IMS,BHU |
| Address |
Room no.6,3rd floor, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,IMS,BHU,Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08290219041 |
| Fax |
|
| Email |
chandadhakad002@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Conservative dentistry and Endodontics,Faculty of dental sciences,IMS,BHU,Varanasi 221005. |
|
|
Primary Sponsor
|
| Name |
Dr Chanda dhakad |
| Address |
Room no.6,3rd floor, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,IMS,BHU,Varanasi 221005 |
| 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 Neelam Mittal |
FDS,IMS,BHU |
Room no.6,3rd floor, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,IMS,BHU,Varanasi 221005
Varanasi
UTTAR PRADESH |
09415203360
drneelamittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee ,IMS,BHU,Varanasi 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined regenerative endodontic treatment and vital pulp therapy |
Under local anesthesia and rubber dam isolation, access cavity is prepared, coronal pulp is removed from orifices of canals either mesial or distal and stop bleeding using cooton pellet saturated with 1.5 percent NaOCl , 3mm thickness of MTA is placed over that orifice and sealed with GIC and composite resin simultaneously negotiate the rest of canals, thoroughly irrigate and Calicium hydroxide dressing is placed and sealed temporarily. After 3 week TF is removed and irrigate thoroughly and PRF is placed using endodontic plugger and 3mm thick MTA is placed over the orifice of canal sealed with GIC composite resin.Pateint recalled after 1 month,3 month,6 month and 9 month for follow up. Duration of study 2 year. |
| Comparator Agent |
Conventional root canal treatment |
Under local anesthesia and rubber dam isolation access cavity is prepared and negotiate the canals using k file, biomechanical preparation is done, irrigate thoroughly using 3 percent NaOCl and obturate with gutta percha cone and restored access cavity using composite resin. |
| Intervention |
Regenerative endodontic procedure |
Under local anesthesia and ruuber dam isolation access cavity is prepared, canal is negotiate using K file and irrigate and Calcium Hydroxide dressing placed and temporarily sealed, after 3 week TF is removed and irrigate the canals and PRF is placed using endodontic plugger, 3mm thickness of MTA will be placed over canal orifices,restord with GIC and composite resin. Pateint recalled after 1 month,3 month,6 month,9 month. Duration of study 2 year. |
| Intervention |
Vital pulp therapy |
Under local anesthesia and rubber dam isolation,access cavity is prepared coronal pulp is removed using high speed hand peice and bleeding controlled using cotton pellet saturated with NaOCl. 3mm thickness of MTA will be placed over canal orifices,restord with GIC and composite resin. recalled after 1 month,3 month,6 month,9 month for follow up and study of duration 2 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1 Permanent mature mandibular molar teeth with clinical signs of pain,sensitivity,tender on percussion and with periapical pathology.
2 Periapical index score 3 and 4 are included
3 Pateint not allergic to medicaments and antibiotics which is necessary to complete procedure. |
|
| ExclusionCriteria |
| Details |
1 Immature permanent mandibular tooth.
2 Teeth with poor prognosis and required extraction.
3 periapical index score more than 4 are not included.
4 Teeth with active pathological root resorption.
5 teeth require post and core for its reinforcement.
6 Medically compromised pateint with systemic condition that is compromised healing responce or cause bleeding tendency.
7 Pateint allergic to medicament and antibiotics necessary for the procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of clinical signs and periapical pathology |
3 months,6 months,9 months,12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Positive response to pulp vitality testing |
3 month,6 month 9 months,12 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/10/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The foundation of restorative dentistry rest on principles that the maintenance of a healthy and functional pulp dentin complex would result in successful healing of exposed pulp. Like other connective tissue, pulp tissue has potential to heal. Root canal treatment is indicated in permanent mature teeth with pulpal and peri radicular diseases which involves complete removal of pulp tissue from the root canals, disinfection and restoring them with bioinert materials. Root canal treatment is non-conservative, non-biological and also expensive, time consuming and tooth becomes non-vital. The current scenario of endodontology has been shifted towards more biological treatment. The pulp dentin complex has the potential to regenerates even if the tooth has symptoms indicative of irreversible pulpitis. Pulpitis caused by caries is the main reason for root canal treatment. Instead of complete pulp tissue removal by pulpectomy, combined regenerative endodontic and vital pulp therapy is a conservative therapy as regenerative endodontic procedure is a biological based procedure that regenerate and repairs lost tooth structure and vital pulp therapy focuses on preserving and promoting the health of the remaining vital pulp tissue. |