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Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05190406
Enrollment
100
Registered
2022-01-13
Start date
2021-06-01
Completion date
2022-08-01
Last updated
2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

pulpitis, pulpotomy, single visit root canal treatment, bioceramic material

Brief summary

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Detailed description

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Interventions

PROCEDUREPulpotomy

After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.

PROCEDUREroot canal treatment

Single visit root canal treatment will be done according to standard protocol.

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

outcome assessor will be blinded

Eligibility

Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Mature permanent restorable mandibular molar teeth. * Tooth should give positive response to pulp sensibility testing. * Clinical diagnosis of irreversible pulpitis with PAI score≤2. * Tooth with probing pocket depth and mobility are within normal limits. * Non-contributory medical history.

Exclusion criteria

* Teeth with immature roots. * No pulp exposure after caries excavation. * Bleeding could not be controlled in 6 minutes. * Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic. * Absence of antagonist tooth. * Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis * Had taken analgesic in past 3 days. * Tooth with periapical lesion visible on radiograph

Design outcomes

Primary

MeasureTime frameDescription
Clinical success rate6 months and one yearClinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Radiographic success rate6 months and one yearRadiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2

Secondary

MeasureTime frameDescription
Oral Health related quality of Lifebaseline to one week, 6 months and one yearOral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life.
Pain assessmentbaseline to one weekVisual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain.

Countries

India

Contacts

Primary ContactDR. Pankaj Sangwan, MDS
drps_1@yahoo.co.in9996112202
Backup ContactKanagadurga R, MDS
durga200295@gmail.com9751505590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026