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

NCT06420583 | Not Yet Recruiting

• 1 other identifier: 2111991
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis

Keywords

first permanent molar; pulpotomy; extraction; oral health related quality of life; post operative pain; visual analog scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral health related quality of life

  12 months

Other Outcomes (1)

• Clinical and radiographic success

  12 months

Study Arms (2)

Pulpotomy

EXPERIMENTAL

MTA Pulpotomy

Procedure: MTA pulpotomy

Extraction

ACTIVE COMPARATOR

Extraction

Procedure: Extraction

Interventions

MTA pulpotomy 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.

Also known as: vital pulp therapy

Pulpotomy

Extraction PROCEDURE

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

Extraction

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

EG (1)