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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: MTA pulpotomy; Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university
    • Contact: Aya A AboElMagd, M.Sc; Phone Number: +201016794067; Email: aya.aboelmagd@dentistry.cu.edu.eg
    • Contact: Passant Nagi, Ph.D; Phone Number: +201280557107; Email: passant.nagi@dentistry.cu.edu.eg
    • Principal Investigator: Hala M Abbas, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulpotomy; MTA Pulpotomy	Procedure: MTA pulpotomy; 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.; 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.; The tooth will be restored with a stainless steel crown.; Other Names: vital pulp therapy
Active Comparator: Extraction	Procedure: Extraction; After complete Anesthetic application in the affected area, non-surgical extraction will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	will be measured using visual analog scale (VAS) The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.	24 hours post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health related quality of life	will be measured using Child Oral Impact on Daily Performances. It consists of 25 items distributed among 4 domains: oral symptoms, functional limitations, emotional well-being, and social well-being. It is self-reported by 8-10-year-old children using a 5-point Likert scale, and responses range from 0-4 for each item. Total scores range from 0 to100, and higher scores indicate poorer OHRQoL	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic success	clinical absence of signs and symptoms of infection, inflammation, swelling , pain and mobility Radiographic absence of periapical radiolucency	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: post operative pain; pulpotomy; visual analog scale; extraction; oral health related quality of life; first permanent molar
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis
• Other Study ID Numbers: 2111991

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No