Clinical trial NCT06420583: Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: first permanent molar
pulpotomy
extraction
oral health related quality of life
post operative pain
visual analog scale
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post operative pain
timeFrame: 24 hours post operatively
Secondary outcomes:
measure: Oral health related quality of life
timeFrame: 12 months
Other outcomes:
measure: Clinical and radiographic success
timeFrame: 12 months
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: