Assessment of the procedure duration and success of alternative emergency treatments for patients with painful dental pulp disease

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN14290358
• Date of registration: 08/06/2017
• Prospective Registration: No
• Primary sponsor: Baskent University
• Public title: Assessment of the procedure duration and success of alternative emergency treatments for patients with painful dental pulp disease
• Scientific title: Assessment of the procedure duration and efficacy of pulpotomy and partial pulpectomy in comparison with total pulpectomy for patients with symptomatic irreversible pulpitis: a randomized clinical trial
• Date of first enrolment: 20/04/2016
• Target sample size: 66
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14290358
• Study type: Interventional
• Study design: Single-blinded single-centre randomised controlled trial (Treatment)

Countries of recruitment

Turkey

Contacts

• Name: Emel Olga Onay

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years
2. Male or female
2. Acute dental pain in posterior maxillary or mandibular molar teeth
4. Diagnosed with symptomatic irreversible pulpitis with or without symptomatic apical periodontitis
Exclusion criteria: 1. History of American Society of Anesthesiologists (1963) III-VI status
2. Pregnancy or nursing
3. Mental disability
4. History of allergy to nonsteroidal anti-inflammatory drugs, and analgesic treatment during the 12 hours prior to presentation
5. If the subject tooth has moderate or severe marginal periodontitis, horizontal or vertical fractures, internal or external root resorption, root canal calcification, or a nonrestorable crown defect
6. If an opposing and/or neighbouring tooth has defective restorations, deep caries, moderate or severe marginal periodontitis, wear, or history of recent tooth preparation.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Symptomatic irreversible pulpitis
Oral Health
Symptomatic irreversible pulpitis

Intervention(s)

Participants are randomised to one of three groups using sealed envelope randomisation.

Intervention group 1: Participants undergo pulpotomy treatment during a single-visit. This involves removing the coronal pulp tissue with a sterile curette, which followed by achieving haemostasis using dry cotton pellets and applying light pressure, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per pulpotomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Intervention group 2: Participants undergo partial pulpectomy treatment during a single-visit. This involves removing the pulp tissue from the pulp chamber and the largest canal (i.e. the palatal canals of maxillary molars and distal canals of mandibular molars) with sterile curettes and barbed broaches, which followed by working length determination, cleaning and initial shaping procedures, dressing, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per partial pulpectomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Control group: Participants undergo conventional total pulpectomy treatment during a single-visit. This involves removing the entire pulp tissue from the tooth with barbed broaches, which followed by working length determination, cleaning and initial shaping procedures, dressing, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per total pulpectomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Follow up takes place once the anaesthetic effect has disappeared (Day 0), and subsequently on days 1, 3, and 7 post-procedure and involves recording three pain measures: postoperative pain intensity (

Primary Outcome(s)

1. Pain intensity is measured using a visual analogue scale (VAS) at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
2. Pain relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in pain intensity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)
3. Total time per procedure per tooth is expressed in minutes during surgery

Secondary Outcome(s)

1. Daily analgesic requirements from the time the anaesthetic wore off (Day 0) throughout the 7 days post-surgery is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the frequencies and amounts of analgesic use per patient at Day 0, and 1, 2, 3, 4, 5, 6, and 7 days post-treatment
2. Proportion of patients with thermal sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
3. Thermal sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of thermal sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)
4. Proportion of patients with chewing sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
5. Chewing sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of chewing sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)

Secondary ID(s)

D-KA16/08

Source(s) of Monetary Support

Baskent Üniversitesi

Ethics review

Status:
Approval date:
Contact:

Baskent University Institutional Review Board and Ethics Committee, 15/04/2016, ref: D-KA16/08.

Results

• Results available: Yes
• Date Completed: 04/04/2017