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Comparative effectiveness of minimally invasive caries-control treatment versus conventional invasive treatment for cavitated painful primary molars in children.

Clinical efficacy of Pulpotomy Versus Pulpectomy procedures in primary molars diagnosed with symptomatic irreversible pulpitis: A Non Inferiority Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113894
Enrollment
90
Registered
2026-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Pulpotomy: Pulpotomy is a vital pulp therapy procedure performed in primary teeth or immature permanent teeth when inflammation is limited to the coronal pulp and the radicular pulp rem

Sponsors

Sarwat Fatema
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy ASA I and II and co-operative children Frankl scale 3 and 4 between the ages of 4 to 9 years with symptoms of irreversible pulpitis in primary molars spontaneous unprovoked pain lasting few seconds to several hours in the days before the dental visit or pain that is exacerbated by hot and or cold stimuli and lingering even after removal of stimuli. Teeth with intraoperative confirmation of vitality of radicular pulp by visual inspection of haemostasis of pulpal haemorrhage within 5 minutes. Restorable primary molars with deep occlusal or proximal caries ICDAS score 4, 5, or 6 without swelling, abscess, sinus, and pathological mobility. No obvious furcal or periapical pathological changes on the radiograph with physiologic root resorption, if present, is less than one third the normal root length.

Exclusion criteria

Exclusion criteria: Teeth with clinical symptoms indicative of dental pulp inflammation other than the symptomatic irreversible pulpitis. Teeth with furcal periapical pathological changes on the radiograph and or physiologic root resorption more than one third of the normal root length and or associated external or internal root resorption. Teeth with intraoperative findings suggestive of necrosis of the radicular pulp and or irreversible inflammation with the radicular pulp as demonstrated by prolonged bleed more than 10 minutes. Patient with systemic conditions influencing the study objectives.

Design outcomes

Primary

MeasureTime frame
Comparative evaluation of the clinical and radiographic success of full pulpotomy and pulpectomy for the management of primary molars diagnosed with symptomatic irreversible pulpitis.Timepoint: 6 months

Secondary

MeasureTime frame
To evaluate patient comfort during pulpotomy, and pulpectomy clinical procedures using the SEM (Sound, Eye, Motor) scale. To evaluate chairside clinical time required to perform pulpotomy and pulpectomy procedures. Timepoint: 6 and 12 months

Countries

India

Contacts

Public ContactSarwat Fatema

All India Institute of Medical Sciences

captainrahul88@gmail.com9855501651

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026