FE in Anterior Teeth

Not Applicable

• Conditions: Pain, Postoperative; Apical Periodontitis
• Interventions: Procedure: Foraminal enlargement

• Registration Number: NCT03527602
• Lead Sponsor: Isparta Military Hospital

Brief Summary

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with 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 in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

Study Timeline

• Study Start: 2017-11-05
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Mature permenent maxillary anterior 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 maxillary anterior 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 rotary 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.

Primary Outcome Measures

Name	Time	Method
100-mm Visual Analog Scale (VAS).	5 days	The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Secondary Outcome Measures

Name	Time	Method
The number of patients taking an analgesic following the endodontics treatment.	5 days	The patients were asked to take an analgesic in the 5 days of time frame.

Trial Locations

Locations (1)

Isparta Military Hospital; 🇹🇷 Isparta, Turkey