Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure (PULPOTOMY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03522051|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulpotomy||Other: calcium silicate based material,||Not Applicable|
Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.
The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.
Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure|
|Actual Study Start Date :||December 1, 2016|
|Actual Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Patients with carious teeth
female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.
Other: calcium silicate based material,
Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation
Other Name: Neo MTA plus, Avalon Biomed
- Change in pain symptoms [ Time Frame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years. ]The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.
- Periapical normalcy at follow up radiographs . [ Time Frame: 6months , 1 year, 2, 3,4,5 years ]
Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years.
no emerging pathosis should be evident in the roots or surrounding bone.
- The tooth and restoration should be present in the mouth [ Time Frame: 3, 6 months, 1 year, 2, 3,4,5 years ]The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522051
|Jordan University of science and technology|
|Irbid, Jordan, 22110|
|Study Director:||Nessrin A Taha, PhD||Jordan University of Science and Technology|