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Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

Not Applicable
Conditions
Pulpitis - Irreversible
Interventions
Procedure: Partial pulpotomy
Procedure: Miniature pulpotomy
Registration Number
NCT05406557
Lead Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Brief Summary

This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

Detailed Description

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.

Once included, study subjects will be randomly allocated to either Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in same appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
86
Inclusion Criteria
  • The patient with18 -45 years of age.
  • Restorable molar teeth.
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of symptomatic partial irreversible pulpitis.
  • Tooth with probing pocket depth and mobility are within normal limits.
  • No signs of pulpal necrosis including sinus tract or swelling.
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Partial pulpotomyPartial pulpotomyRemoval of superficial 2-3 mm of pulp tissue from entire pulp chamber
Miniature pulpotomyMiniature pulpotomyRemoval of superficial 2-3 mm of pulp tissue from only affected pulp horn
Primary Outcome Measures
NameTimeMethod
Clinical and radiographic successBaseline to 12 Months

Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.

RADIOGRAPHIC SUCCESS CRITERIA:

No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.

Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique.

Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.

Secondary Outcome Measures
NameTimeMethod
Pain analysisBaseline to 7 days

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

Pulp sensibility testingBaseline to 12 months

To assess pulp tissue response using cold and electric pulp test at 6 and 12 months

Trial Locations

Locations (1)

Dr. Ankita Ramani

🇮🇳

Rohtak, Haryana, India

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