| CTRI Number |
CTRI/2025/07/090149 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three regenerative materials used for treating decayed tooth in children: A clinical Study |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CLINICAL AND RADIOGRAPHICAL SUCCESS IN MINERAL TRIOXIDE AGGREGATE, BIOCERAMIC AND NANOHYRDROXYAPATITE AS PULPOTOMY MEDICAMENT IN PRIMARY MOLARS - 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 |
ELANCHEZHIYAN P |
| Designation |
POST GRADUATE |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Room no:6, first floor,Department of Pediatric and Preventive Dentistry,
Melmaruvathur-603319.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9444316963 |
| Fax |
|
| Email |
drelanchezhiyanpedo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SELVABALAJI A |
| Designation |
Professor |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Room no:6, first floor,Department of Pediatric and Preventive Dentistry,
Melmaruvathur-603319.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9003604774 |
| Fax |
|
| Email |
selvabalaji88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ELANCHEZHIYAN P |
| Designation |
POST GRADUATE |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Room no:6, first floor,Department of Pediatric and Preventive Dentistry,
Melmaruvathur-603319.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9444316963 |
| Fax |
|
| Email |
drelanchezhiyanpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental OPD in Adhiparasakthi Dental College and Hospital and Dental camps Room no:6, first
floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and
Hospital, Melamruvathur-603319, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Elanchezhiyan P |
Adhiparasakthi dental college and hospital |
Room no:6, first floor,
Department of Pediatric
and Preventive
dentistry,
Melmaruvathur-603319.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9444316963
drelanchezhiyanpedo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board- Adhiparasakthi Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioceramic and Nanohydroyapatite pulpotomy |
Working procedures: Personal, medical, and dental histories were obtained from all children participating in this study. Diagnostic preoperative periapical radiographs using RVG were taken for all molars. The pulpotomy procedure was initiated by administering topical anesthesia, followed by local anesthesia using 2% lidocaine with 1:100,000 epinephrine, ensuring adequate anesthesia of the primary molar to be treated. Rubber dam isolation was employed to maintain a clean and dry operative field. The carious lesion was thoroughly identified and completely removed. Upon pulpal exposure, access to the pulp chamber was obtained using a high-speed 330 tungsten carbide bur under air-water coolant. The chamber was subsequently unroofed and refined with a slow-speed round steel bur. Coronal pulp tissue was carefully amputated using either a slow-speed large round bur (size 6–8) or a sharp spoon excavator, and all remnants were eliminated up to the level of the root canal orifices. The exposed radicular pulp was gently irrigated with sterile saline, and a moistened cotton pellet was placed over the orifices until hemostasis was achieved, typically within four minutes. Based on the assigned study group, the following pulpotomy medicaments was applied: Bioceramic Putty or Nano-Hydroxyapatite. A layer of GIC was then placed over the medicament, and the tooth was restored with an appropriately sized prefabricated stainless-steel crown. Patients were recalled at 1, 3, and 6 months postoperatively for clinical and radiographic evaluations, during which the treated teeth were assessed and classified as either successful or failed based on predetermined clinical and radiographic criteria. |
| Comparator Agent |
Mineral trioxide oxide pulpotomy |
Working procedures: Personal, medical, and dental histories were obtained from all children participating in this study. Diagnostic preoperative periapical radiographs using RVG were taken for all molars. The pulpotomy procedure was initiated by administering topical anesthesia, followed by local anesthesia using 2% lidocaine with 1:100,000 epinephrine, ensuring adequate anesthesia of the primary molar to be treated. Rubber dam isolation was employed to maintain a clean and dry operative field. The carious lesion was thoroughly identified and completely removed. Upon pulpal exposure, access to the pulp chamber was obtained using a high-speed 330 tungsten carbide bur under air-water coolant. The chamber was subsequently unroofed and refined with a slow-speed round steel bur. Coronal pulp tissue was carefully amputated using either a slow-speed large round bur (size 6–8) or a sharp spoon excavator, and all remnants were eliminated up to the level of the root canal orifices. The exposed radicular pulp was gently irrigated with sterile saline, and a moistened cotton pellet was placed over the orifices until hemostasis was achieved, typically within four minutes. Mineral Trioxide Aggregate pulpotomy medicaments was applied. A layer of GIC was then placed over the medicament, and the tooth was restored with an appropriately sized prefabricated stainless-steel crown. Patients were recalled at 1, 3, and 6 months postoperatively for clinical and radiographic evaluations, during which the treated teeth were assessed and classified as either successful or failed based on predetermined clinical and radiographic criteria. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Primary molars with deep caries lesion without spontaneous pain
Vital carious pulp exposures that bleed upon entering the pulp chamber
Tooth with at least two thirds of root length
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients and uncooperative patients.
Children whose parents who did not give the consent.
Teeth shows the signs and symptoms of abscess, fistula, sinus tract and mobility.
Teeth show radiographic of pathologic root resorption, interradicular bone loss.
Periapical pathology and calcifications in the canal were excluded from the trial.
|
|
|
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 |
| All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology). |
at baseline, 1 month, 3 months and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause morbidity at 1, 3 and 6 months. Incidence of post-operative pain and patient satisfaction by Five point likert scale. |
at baseline, 1 month, 3 months and 6 month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial compared the clinical and radiographic success of three pulpotomy medicaments in primary molars: Mineral Trioxide Aggregate (MTA), Bioceramic Putty, and Nano-Hydroxyapatite (nHA). Personal, medical, and dental histories were collected from all participants. Preoperative diagnostic radiographs were taken using RVG. The pulpotomy procedure involved local anesthesia, rubber dam isolation, complete caries removal, and coronal pulp amputation under sterile conditions. Hemostasis was achieved with saline and a moistened cotton pellet. The assigned medicament was then applied over the radicular pulp: MTA for Group I, Bioceramic Putty for Group II, and nHA for Group III. A zinc oxide eugenol base was placed over the medicament, and the tooth was restored with a stainless steel crown. Follow-up evaluations were conducted at 1, 3, and 6 months to assess clinical and radiographic outcomes.
The study aims to explore viable alternatives to MTA, which is considered the gold standard. Bioceramic materials may offer advantages such as easier handling, quicker setting time, and cost-effectiveness. nHA, due to its bioactivity and regenerative potential, could provide a more biocompatible option. These alternatives could enhance the accessibility of pulpotomy treatment, especially in low-resource areas. The findings contribute to evidence-based pediatric endodontics and support the continued development of innovative dental biomaterials. Effective pulpotomy medicaments help in maintaining arch length, supporting proper eruption of permanent teeth, and minimizing the need for invasive treatments. |