NCT06420583

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

Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction for the Management of Permanent First Molar With Poor Prognosis: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Extraction	After complete Anesthetic application in the affected area, non-surgical extraction will be done.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: Egypt