Foraminal Enlargement and Postoperative Pain.

Phase 1

Completed

• Conditions: Pain Postoperative
• Interventions: Procedure: Foraminal enlargement

• Registration Number: NCT02770053
• Lead Sponsor: Isparta Military Hospital

Brief Summary

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Detailed Description

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-02
• Status Verified: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Mature permenent teeth having pulpal necrosis and apical periodontitis.

Exclusion Criteria

• Systemic disorders
• Diabetes
• Pregnancy
• Less than 18 years of age
• Immunocompromised
• Patients who had taken antibiotics in the past 1 month
• Patients who had a positive history of analgesic use within the past 3 days
• Previously accessed teeth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Foraminal enlargement	Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit.
Control	Foraminal enlargement	In the control group, no foraminal enlargement will be performed.

Primary Outcome Measures

Name	Time	Method
4-step pain intensity measures using a Visual Analog Scale (VAS).	7 days.	The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.

Secondary Outcome Measures

Name	Time	Method
The number of patients taking an analgesic following the endodontics treatment.	7 days.	The patients were asked to take an analgesic in the 7 days of time frame.