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NCT03718676 Clinical Trial

Pulpotomy With Various MTA Materials and Ferric Sulphate

Pulpotomy Clinical Trial

Official title:
Clinical and Radiographic Comparison of RetroMTA, OrthoMTA And Ferric Sulfate for Pulpotomy in Primary Molars

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03718676
Other study ID # 2018-047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2017
Est. completion date December 30, 2018

Study information
Verified date October 2018
Source Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.

Description:

A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date December 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 9 Years
Eligibility Inclusion Criteria:

- Patients have at least three deep carious primary second molars

- Teeth with no spontaneous pain

- Patient who are willing to participate

- Cooperative children

Exclusion Criteria:

- Patients who are not willing to participate

- History of systemic disease

- Pathological mobility

- Presence of internal or external root resorption

- Presence of apical radiolucency

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ferric sulphate
Teeth were pulpotomized with ferric sulphate in this group.
• Ortho-MTA
Teeth were pulpotomized with Ortho-MTA in this group.
• Retro-MTA
Teeth were pulpotomized with Retro-MTA in this group.

Locations
Country Name City State
Turkey Sultan KELES Aydin

Sponsors (1)
Lead Sponsor Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical success rate Clinical success Change of clinical success from Baseline at 18 months
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