Irreversible Pulpitis Clinical Trial
Official title:
Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial
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.
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 - |
Country | Name | City | State |
---|---|---|---|
India | PIGDS | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
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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