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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06433245
Other study ID # Ridhi Karwal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 23, 2024
Est. completion date December 23, 2025

Study information

Verified date May 2024
Source Postgraduate Institute of Dental Sciences Rohtak
Contact Dr. Pankaj Sangwan, MDS
Phone 9996112202
Email drps_1@yahoo.co.in
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. The main question it aims to answer are: 1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis. 2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.


Description:

TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial. Question it aims to answer: Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis. I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up. 2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months. In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date December 23, 2025
Est. primary completion date December 23, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 40 Years
Eligibility Inclusion Criteria: 1. Mature permanent mandibular molars. 2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis 3. Patients having normal periapical status with periapical index (PAI) score = 2 4. Periodontally healthy teeth 5. Patients having physical status of class 1 or 2 according to ASA classification 6. Pulpal bleeding can be controlled within 6 minutes. 7. Presence of extremely deep carious lesion on radiograph - Exclusion Criteria: 1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Locations

Country Name City State
India PIGDS Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical success rate Clinical criteria of success:-
No pain or discomfort except for the first few days after treatment.
No tenderness to palpation or percussion and the tooth is functional.
Normal mobility and probing pocket depth.
Healthy soft tissues around teeth with no swelling, sinus tract.
baseline to 12 months
Primary Radiographic success rate Radiographic success criteria:-
No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph.
Complete radiographic healing
Baseline to 12 months
Secondary Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain Baseline to 7 days
Secondary OHRQoL assessment OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale:
never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.
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