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Efficacy of calcium-enriched mixture cement, mineral trioxide aggregate and calcium hydroxide used as direct pulp capping agents in deep carious lesions - a randomised clinical trial.

Comparative evaluation of calcium enriched mixture (CEM cement) with mineral trioxide aggregate and calcium hydroxide used as direct pulp capping agents- an in vivo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44317435
Enrollment
150
Registered
2022-08-11
Start date
2011-03-22
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Patients complaining of pain in relation to deep carious lesions while having food or drinks diagnosed clinically and radiographically to be having reversible pulpitis. Oral Health

Interventions

The study includes 150 patients selected from the Out Patient Department Of Conservative Dentistry & Endodontics, Govt. Dental College Kozhikode with symptoms of reversible pulpitis in relation to dee

Sponsors

Government Dental College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Teeth having deep carious lesion approximating the pulp. 2. Have symptoms of reversible pulpitis which includes provoked pain of short duration which was relieved upon removal of the stimulus in relation to the carious tooth. 3. No history of spontaneous pain or tenderness to percussion. 4. Patients in the age group of 14- 60 years who are apparently healthy and free of any systemic disease and are not under any medication. 5. Good oral health. 6. Positive response to cold test and electric pulp test 7. Periapical Index Score (PAI) = 1 indicating normal periradicular structures. 8. Teeth which are not subjected to traumatic or abnormal functional stresses. 9. Absence of any non carious destructions and developmental defects 10. No appreciable mobility to finger pressure 11. No clinical or radiographic evidence of pulp degeneration 12. Absence of profuse haemorrhage from the exposure site. 13. Absence of serous or purulent exudates from the exposure site. 14. Control of haemorrhage is possible at the exposure site in less than 5 minutes

Exclusion criteria

Exclusion criteria: 1. Patients with compromised immune status 2. Patients who are pregnant at the time of follow-up 3. Caries have extensively penetrated the pulp chamber 4. Tooth showing symptoms of irreversible pulpitis 5. Bleeding from the exposure site persists for more than 5 minutes

Design outcomes

Primary

MeasureTime frame
The criteria for success and failure of direct pulp capping were assessed based on clinical and radiographic findings at each of the follow-up periods at 1 month,3 months, 6 months, 12 months and 18 months in comparison to the preoperative clinical and radiographic data. 1. Pain in relation to the capped tooth assessed using the Visual Analog Scale (VAS) graded from 0-10 recorded and compared in each of the follow up examinations. 2. Tenderness to percussion and palpation- present or absent 3. Measurement of probing depth in each of the follow up examinations using WHO probe. 4. Mobility of tooth assessed using blunt end of two mouth mirrors and graded as 1 to 3 5. Vitality was assessed on the tooth treated using cold test (ENDO FROST PULP TESTER) and Electric pulp tester (Gentle –Pulse Pulp vitality tester, Parkell Electronics,Farmingdale, NY, USA) and scores assigned from 0-10 in relation to adjacent and contralateral teeth and compared with the previous scores in each of the follow up examinations 6. Radiographic evaluation included assessment of the periradicular condition of the selected teeth using Peri Apical Index Scoring System (PAI Score.)

Secondary

MeasureTime frame
At 1 month,3 months, 6 months, 12 months and 18 months 1. Whether root canal therapy done in any of the follow up examinations yes/no 2. Whether extraction done in any of the follow up examinations yes/no 3. Whether sinus tract present or absent yes/no 4. Whether root resorption present or absent yes/no

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026