Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

Irreversible Pulpitis Clinical Trial

Official title:

Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561183
• Other study ID #: IKHDC: 01-11-1390
• 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
• 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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

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