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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Irreversible Pulpitis

Treatments: Procedure: Extraction; Procedure: MTA pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06420583

2111991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Pulpotomy

Experimental group

Description:

MTA Pulpotomy

Treatment:

Procedure: MTA pulpotomy

Extraction

Active Comparator group

Description:

Extraction

Treatment:

Procedure: Extraction