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Pulpotomy with Formocresol, Calcium Enriched Mixture cement and Sodium Hypochlorite 5%

Comparing the effects of Sodium Hypochlorite 5% and Calcium Enriched Mixture cement versus Formocresol on clinical and radiographic outcomes of pulptherapy of primary molars in children 5-8 years old_ A clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013092414749N1
Enrollment
Unknown
Registered
2014-03-16
Start date
2012-11-05
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

pulpitis. ?????? ??? ???? ? ???? ??? ????? ????

Interventions

Intervention 1: Intervention group: 1. After pulp amputation and hemostasis occurring: CEM cement paste(Bionique Dent-Iran), obtained by mixing CEM cement powder with distilled water provided in 3
Treatment - Drugs
Intervention group: 1. After pulp amputation and hemostasis occurring: CEM cement paste(Bionique Dent-Iran), obtained by mixing CEM cement powder with distilled water provided in 3:1 ratio, then w
1. Intervention group 2. After the standard pulp-therapy, a cotton pellet soaking in 5% Hypochlorite sodium (pak daroo) was placed in chamber for 30 seconds and then pulp chamber was washed out with n
Control group: 1. After completion of pulp therapy, the control teeth were treated with sterile cotton pellet moistened with Formocresol (Sultan) which was placed in pulp chamber for 5 minutes and the

Sponsors

Vice chancellor for research, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Children who will be able to cooperate in order to primary teeth pulp-therapy. 2. All primary molars should be exposed due to decay and pulp should be vital. 3. Absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction in a preliminary radiograghy 4. There should not be any clinical signs of pulp degeneration such as spontaneous pain, fistula, mobility, swelling and sinus tract prior to treatment. 5. All teeth should be restorable with Posterior Stainless Steel Crown. Exclusion criteria: 1. Parents who are opposed to participation in the study. 2. The children out of 5-8 age range. 3. Patients with a history of systemic disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mobility. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: By dental mirror on one side of tooth and fingers on the other side.;Swelling. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: With clinical observation.;Sinus tract and puss discharge from orifices of canals. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: With clinical observation.;Internal resorption. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: Graphic evaluation.;Furcation lesion. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: Graphic evaluation.;Peri apical destruction. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: Graphic evaluation.;Involvement of periodontal ligament. Timepoint: 3, 6 and 12 months after treatment. Method of measurement: Graphic evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ebrahim Jabarifar

Isfahan University of Medical Sciences, Dental School

jabarifar@dnt.mui.ac.ir+98 31 1792 2891

Outcome results

None listed

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