| CTRI Number |
CTRI/2024/09/073481 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Outcome of full pulpotomy and root canal treatment in deeply carious mature permanent teeth involving tooth pulp and periapical region. |
|
Scientific Title of Study
|
Outcome of full pulpotomy
compared to root canal treatment in cariously exposed mature permanent teeth with signs of symptomatic irreversible pulpitis and apical
radiolucency: A randomized
controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IM/NF/18/2024-25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Galani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rajkot |
| Address |
Department of Dentistry, All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA.
Rajkot
GUJARAT
360006
India |
| Phone |
8053456519 |
| Fax |
|
| Email |
drmohitgalani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Galani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rajkot |
| Address |
Department of Dentistry, All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA.
Rajkot
GUJARAT
360006
India |
| Phone |
8053456519 |
| Fax |
|
| Email |
drmohitgalani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Galani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rajkot |
| Address |
Department of Dentistry, All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA.
Rajkot
GUJARAT
360006
India |
| Phone |
8053456519 |
| Fax |
|
| Email |
drmohitgalani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA- 360006 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mohit Galani |
All India Institute of Medical Sciences, Rajkot,Gujarat, India. |
Room no. 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat, India.
Rajkot
GUJARAT |
8053456519
drmohitgalani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full(Coronal) pulpotomy. |
After taking informed consent, the patients will be scheduled for treatment. Teeth will be anesthetized using 3ml 2% lignocaine hydrochloride with epinephrine 1:1,00,000 (Lox 2%; Neon Lab, New Delhi, India) given as nerve block and isolated under rubber dam. Entire carious tissue will be excavated using a large round diamond bur in airotor handpiece with water coolant and spoon excavators. Then the cavity will be cleaned with 2.5% sodium hypochlorite. Using fresh sterile round bur, the pulp chamber will be entered and deroofed using tapered safety ended diamond bur (EndoAccess Bur; Dentsply Maillefer, Tulsa, OK). Coronal pulp tissue will be excised using a spoon excavator until the canal orifice, and hemorrhage will be controlled using damped cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) applied for maximum of 10minutes. If haemorrhage cannot be controlled the case will be excluded. After hemorrhage control, the chamber will be cleaned using 5 mL of 2.5% NaOCl. In the pulpotomy(intervention) group, freshly mixed paste of white mineral trioxide aggregate (MTA) (Pro-Root MTA White; Dentsply Maillefer) will be placed over the chamber floor covering the pulpal floor and orifices till it is 2-4mm thick confirmed on radiograph. A damped cotton pellet will be placed and cavity will be restored using interim restoration. Patient will be recalled for final restoration (composite) after 3-4 days. Then the patient will followed up at every 3 months for 1 year for clinical and radiographic evaluation. |
| Comparator Agent |
Root canal treatment |
Root canal treatment (comparator group) is the standard treatment of cariously involved permanent tooth with signs and symptoms of irreversible pulpitis and apical periodontitis.
Teeth will be anesthetized using 3ml 2% lignocaine hydrochloride with epinephrine 1:1,00,000 (Lox 2%; Neon Lab, New Delhi, India) given as nerve block and isolated under rubber dam. Entire carious tissue will be excavated using a large round diamond bur in airotor handpiece with water coolant and spoon excavators. Then the cavity will be cleaned with 2.5% sodium hypochlorite. Using fresh sterile round bur, the pulp chamber will be entered and deroofed using tapered safety ended diamond bur (EndoAccess Bur; Dentsply Maillefer, Tulsa, OK). Coronal pulp tissue will be excised using a spoon excavator until the canal orifice, and hemorrhage will be controlled using damped cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) applied for maximum of 10minutes. If haemorrhage cannot be controlled the case will be excluded.
In the RCT group, vital pulp tissue will be extirpated from the canals using hand and rotary instruments. Canal length will be determined using an apex locator (Morita Dentaport Root ZX; J. Morita, Irvine, CA) and prepared using rotary nickel-titanium files to 3 sizes larger than the initial apical binding file. Irrigation will be performed using 5ml of 2.5% NaOCl and 17% EDTA. Irrigant solution will be activated using ultrasonic device. Obturation (filling of root canals) will be done using gutta percha with cold lateral condensation technique in the same visit. Finally the tooth will be restored using composite resin in the next visit. Patient will be followed up at every 3 months till 1 year for clinical and radiographic evaluation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult patients with extremely deep carious first and second mature permanent molars will be included. Teeth should have symtoms of symptomatic irreversible pulpitis and respond positively to pulp vitality tests. Radiograph showing apical radiolucency with periapical index score of less than or equal to 4. |
|
| ExclusionCriteria |
| Details |
Patients having systemic disease, pregnant, immunocompromised,habit of smoking. Teeth with mobility,deep periodontal pocket, swelling,sinus tract, fracture or previously initiated treatment.Third molars will be excluded. Teeth in which haemostasis will not be achieved within 10minutes with damped cotton soaked with sodium hypochlorite. Absence or inaequate bleeding from of bleeding from pulp canals suggesting progressive pulp necrosis. |
|
|
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 |
| Absence of clinical signs and symptoms with healing or reduction in size of apical radiolucency amonst the two groups |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain reduction using VAS scale and analgesic intake. |
During 1 week postoperatively and during followup visits. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
16/09/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmohitgalani@gmail.com].
- For how long will this data be available start date provided 02-03-2026 and end date provided 01-02-2057?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present prospective randomized parallel group active controlled trial will be conducted comparing two treatment modalities i.e. full pulpotomy and root canal treatment. With better understanding of the healing capacity of tooth pulp and advancement in bioactive materials having regenerative potential, vital pulp preservation techniques are being practised in recent times. These techiques were previoulsy restricted to primary teeth or as an emergency treatment before root canal treatment. But recent randomized clinical trials and epidemiological studies have found it to be sucessful in permanent teeth too. Also histological studies have shown that often there is selective inflammation with involvement of coronal pulp while the radicular pulp still has the ability to repair. The standard treatment of deep carious lesion involving pulp with signs and symptoms of irreversible pulpitis and apical radiolucency is root canal treatment. Thus, the aim of present study is to compare clinical and radiographic outcome of full pulpotomy (newer treatment) with gold standard root canal treatment (standard). |