Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar

NCT ID: NCT06420583

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to compare between post operative pain and oral health related quality of life in participants receiving two treatments for first permanent mandibular molars with poor prognosis.

Group I (Experimental group): Complete Pulpotomy with the use of MTA followed by stainless steel crown.

Group II (Control group): Non-surgical extraction.

Detailed Description

The principal investigator will carry out all treatment procedures, and the patients will be assigned.

For both interventions:

1. Informed consent from participating parents.

2. Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection.

3. A diagnostic chart with personal, medical, and dental history will be filled

4. Baseline Oral Health related quality of life questionnaire for each participant.

5. A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).

6. Preoperative and Postoperative photographs will be taken.

7. The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device.

8. Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).

9. Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows:

10. Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulpotomy

MTA Pulpotomy

Group Type: EXPERIMENTAL

MTA pulpotomy

Intervention Type: PROCEDURE

1. Application of rubber dam for isolation, then a standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level, bleeding control in the pulp chamber will be achieved by using 5% sodium hypochlorite.

2. gentle condensation of MTA mix in the pulp chamber will be done by a wet sterile cotton pellet and then the rest of the pulp chamber will be filled with Glass Ionomer restoration.

3. The tooth will be restored with a stainless steel crown.

Extraction

Extraction

Group Type: ACTIVE_COMPARATOR

Extraction

Intervention Type: PROCEDURE

After complete Anesthetic application in the affected area, non-surgical extraction will be done.

Interventions

MTA pulpotomy

1. Application of rubber dam for isolation, then a standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level, bleeding control in the pulp chamber will be achieved by using 5% sodium hypochlorite.

2. gentle condensation of MTA mix in the pulp chamber will be done by a wet sterile cotton pellet and then the rest of the pulp chamber will be filled with Glass Ionomer restoration.

3. The tooth will be restored with a stainless steel crown.

Intervention Type: PROCEDURE

Extraction

After complete Anesthetic application in the affected area, non-surgical extraction will be done.

Intervention Type: PROCEDURE

Other Intervention Names

vital pulp therapy

Eligibility Criteria

Inclusion Criteria

Children aged between 8 years and 9.5 years.

• Decayed Mandibular Permanent first molars.
• Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization)

Exclusion Criteria

• Children who are not apparently healthy.
• Lack of informed consent by the child patient's parent.
• Patients who are allergic to any of the materials used in the procedure.
• Unable to attend follow-up visits.
• Refusal of participation.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Amr Abo ElMagd

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Facility Contacts

Aya A AboElMagd, M.Sc

Role: primary

aya.aboelmagd@dentistry.cu.edu.eg

+201016794067

Passant Nagi, Ph.D

Role: backup

passant.nagi@dentistry.cu.edu.eg

+201280557107

Other Identifiers

2111991

Identifier Type: -

Identifier Source: org_study_id