| CTRI Number |
CTRI/2025/01/079085 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of success of Complete Pulpotomy procedure using two different Calcium Silicate Biomaterials in patients with irreversible pulpitis.
|
|
Scientific Title of Study
|
Comparative Evaluation of the Treatment Outcome of Complete Pulpotomy using two different Calcium Silicate Biomaterials in Mature Permanent Molars with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial with a 1 Year Follow-Up |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pravin Kumar |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur, RAJASTHAN
Pin- 342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Kumar |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur, RAJASTHAN
Pin- 342005
India
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nilovi Swu |
| Designation |
Post Graduate Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur, RAJASTHAN
Pin- 342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8723967085 |
| Fax |
|
| Email |
nilo.nombo27@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Department of Dentistry, Block 2A, OPD Building, Jodhpur
RAJASTHAN 342005 India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni
Basni,Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Government medical 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 Pravin Kumar |
All India Institute of Medical Sciences, Jodhpur |
Endodontic Section
Block 2A second floor
Department of
Dentistry, Marudhar
Industrial Area, 2nd
Phase, M.I.A. 1st
Phase, Basni, Basni,
Jodhpur, Rajasthan
Pin- 342005
India.
Jodhpur
RAJASTHAN |
9818402220
kumarpr@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium Silicate Glass |
An inferior alveolar nerve block with 1.5 mL of 2% lignocaine containing 1:80,000 adrenaline will be used for anesthesia. After confirmation of anesthesia and rubber dam isolation, caries excavation will be performed using a round bur. In all cases, an occlusal access will be made using a sterile round carbide bur at high speed. After gaining access to the pulp chamber, complete deroofing will be done until the bleeding is observed. With the help of a sharp spoon excavator, coronal pulp will be removed up to the level of canal orifices. Irrigation of the chamber will be done with 3% sodium hypochlorite (NaOCl). Hemostasis will be achieved by applying pressure with a cotton pellet and cotton pellet damped in 3% NaOCl for 5 min without pressure and repeated if required for 10 min. Teeth that do not exhibit pulpal hemorrhage or in which hemostasis cannot be achieved within 10 min will be excluded from the study. After achieving hemostasis, pulp stumps will be immediately dressed with calcium silicate Glass biomaterial.
After the initial setting, a layer of light cure glass ionomer cement will be placed and light cured.
Further, the access cavity will be cleaned, dried, and a bonding agent will be applied according to manufacturer instructions. A Giomer material will be used to restore the cavity with incremental technique. Occlusal high points will be checked with articulating paper and will be corrected if required. A final intraoral periapical radiograph will be taken to assess the pulpotomy procedure.
All patients will be instructed to take one tablet of 400 mg ibuprofen in case of pain (maximum up to 3 tablets per day) to be taken for a week. The total duration of the procedure is 1 day.
|
| Comparator Agent |
Tricalcium Silicate Biomaterial |
An inferior alveolar nerve block with 1.5 mL of 2% lignocaine containing 1:80,000 adrenaline will be used for anesthesia. After confirmation of anesthesia and rubber dam isolation, caries excavation will be performed using a round bur. In all cases, an occlusal access will be made using a sterile round carbide bur at high speed. After gaining access to the pulp chamber, complete deroofing will be done until the bleeding is observed. With the help of a sharp spoon excavator, coronal pulp will be removed up to the level of canal orifices. Irrigation of the chamber will be done with 3% sodium hypochlorite (NaOCl). Hemostasis will be achieved by applying pressure with a cotton pellet and cotton pellet damped in 3% NaOCl for 5 min and repeated if required for 10 min. Teeth that do not exhibit pulpal hemorrhage or in which hemostasis cannot be achieved within 10 min will be excluded from the study. After achieving hemostasis, pulp stumps will be immediately dressed with tricalcium silicate biomaterial.
After the initial setting, a layer of light cure glass ionomer cement will be placed and light cured.
Further, the access cavity will be cleaned, dried, and a bonding agent will be applied according to manufacturer instructions. A Giomer material will be used to restore the cavity with incremental technique. Occlusal high points will be checked with articulating paper and will be corrected if required. A final intraoral periapical radiograph will be taken to assess the pulpotomy procedure.
All patients will be instructed to take one tablet of 400 mg ibuprofen in case of pain (maximum up to 3 tablets per day) to be taken for a week.Total Duration of procedure is 1 day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Teeth diagnosed with Symptomatic Irreversible Pulpitis.
2. Mature Permanent molars.
3. Healthy patients (age 18-30 years) without systemic diseases or allergic reactions (ASA I and ASA II).
4. No associated pathologic mobility of the tooth.
5. No significant periapical changes, periapical index (PAI) ≤ 2.
6. Active bleeding pulp tissue observed upon access opening.
7. Hemostasis achieved within 10 min after complete pulpotomy.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with pathologic mobility, associated sinus tract, necrotic pulp tissue (i.e., absence of hemorrhage in pulp chamber), or unrestorable teeth.
2.PAI score more than 2.
3.Teeth with radiolucency in the furcation area, presence of internal or external root resorption, or pulp canal obliteration.
4.Teeth in which hemostasis cannot be achieved within 10 minutes.
5.Individuals not giving written consent.
6.Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the clinical success and radiographic outcome of tricalcium silicate and calcium silicate glass biomaterials following complete pulpotomy in teeth with symptomatic irreversible pulpitis. |
Post-operatively- 24 hours, 3 months, 6 months, and 1 year.
Follow-up radiographs will be taken at 3 months, 6 months, and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To comparatively evaluate the radiopacity of tricalcium silicate and calcium silicate glass biomaterials. |
Time Points-3 months, 6 months, and 1 year.
|
|
|
Target Sample Size
|
Total Sample Size="396"
Sample Size from India="396"
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 4 |
|
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="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
|
The objective of pulpotomy in permanent teeth is to preserve the vitality of the pulp, which exhibits superior healing potential and clinical outcomes compared to direct pulp capping and root canal treatment. Pulpotomy is considered to be advantageous over root canal therapy (RCT) with respect to procedural complexities and economic factors in cases of symptomatic irreversible pulpitis(SIP). The pulpotomy procedures are performed to remove irreversibly inflamed pulp tissue and protect the residual normal/reversibly inflamed pulp tissue. In the literature, two distinct pulpotomy techniques have been described. This includes complete pulpotomy (CP), in which the entire coronal pulp tissue is removed up to the level of the root canal orifice(s) and partial pulpotomy (PP), which involves partial removal of coronal pulp tissue after exposure; prior to the application of a biomaterial and placement of a permanent restoration in both the cases. Based on a systematic review, the average success rate reported for CP was found to be 97.4% clinically and 95.4% radiographically at 12- months follow-up whereas for PP the average success rate reported was 92% at 2-year follow-up in treating cariously exposed permanent posterior teeth diagnosed with SIP. Thus, the aim of this study is to evaluate the clinical and radiographic outcome of complete pulpotomy/VPT procedure performed using tricalcium silicate and calcium silicate glass biomaterials in permanent molars with SIP. The total of 396 patients who meet the inclusion criteria will be enrolled for the clinical trial and two biomaterials will be used to perform complete pulpotomy in teeth diagnosed with symptomatic irreversible pulpitis. |