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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01561183
Other study ID # IKHDC: 01-11-1390
Secondary ID
Status Completed
Phase N/A
First received March 14, 2012
Last updated April 26, 2017
Start date March 2012
Est. completion date December 2016

Study information

Verified date April 2017
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.


Description:

The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date December 2016
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria:

1. Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)

2. Positive response to EPT or cold test

3. patients willing to participate in study

4. Healthy subjects; absence of any systematic disorder

5. Age = 10 years old

6. Both gender

7. Written informed consent

Exclusion Criteria:

1. Moderate or severe periodontitis; pockets >3mm

2. None restorable tooth

3. Internal or external root resorption

4. Root canal calcification

5. Non vital pulps

6. Analgesic taken within the last 8h

7. Active systemic disease

8. Pregnancy or nursing

9. History of opioid addiction/abuse

10. Temporary residency

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Indirect pulp capping (IPC)
Procedure: IPC The IPC will be performed as follow: Anesthesia isolation the tooth access to the lesion incomplete removal of carious tissue from the cavity walls indirect pulp capping with ˜2 mm layer calcium enriched mixture cement permanent filling with sandwich technique
Direct pulp capping (DPC)
Procedure: DPC The DPC will be performed as follow: Anesthesia isolation the tooth access to the lesion complete removal of carious tissue from the cavity walls result in pulp exposure preparation of clot-free pulpal mound direct pulp capping with ˜2 mm layer calcium enriched mixture cement permanent filling with sandwich technique
Miniature pulpotomy (MP)
Procedure: MP The MP will be performed as follow: Anesthesia isolation the tooth access to the lesion complete removal of carious tissue from the cavity walls result in pulp exposure intentionally removal of pulp horn (˜1 mm) preparation of clot-free pulpal mound direct pulp capping with ˜2 mm layer calcium enriched mixture cement permanent filling with sandwich technique
Full pulpotomy (FP)
Procedure: FP The FP will be performed as follow: Anesthesia isolation the tooth access to the lesion complete removal of carious tissue from the cavity walls result in pulp exposure pulpotomy preparation of clot-free pulpal mound direct pulp capping with ˜2 mm layer calcium enriched mixture cement permanent filling with sandwich technique

Locations

Country Name City State
Iran, Islamic Republic of Imam Khomeini Dental Clinic Tehran

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Asgary S, Ahmadyar M. Can miniature pulpotomy procedure improve treatment outcomes of direct pulp capping? Med Hypotheses. 2012 Feb;78(2):283-5. doi: 10.1016/j.mehy.2011.11.002. Epub 2011 Dec 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and radiographical success rates (%) of each treatment group The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection.
The outcome of radiographic success is classified by using a modification of the Strindberg criteria.
1 year
Secondary Patient Assessment of Pain with questionnaire Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete. 6-months
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