Apical Patency and Postoperative Pain.

Phase 1

Completed

• Conditions: Pain Postoperative
• Interventions: Procedure: APICAL PATENCY

• Registration Number: NCT02768285
• Lead Sponsor: Isparta Military Hospital

Brief Summary

The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.

Detailed Description

Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01-01
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2017-07-17
• Study Completion: 2017-08-07
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Mature permanent teeth having plural 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	APICAL PATENCY	Endodontic treatment was performed in posterior teeth with necrotic pulp and periapical periodontitis using a reciprocating single-file system (Reciproc). Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 2.5 % sodium hypochlorite, canal negotiation was done \& apical patency was achieved with #10 K-files in patency group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills was done. The canals were obturated with gutta-percha and epoxy resin sealer. The treatments were carried out in one-visit.

Primary Outcome Measures

Name	Time	Method
100-mm Visual Analog Scale (VAS).	7 days.	Pain severity was evaluated as 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 endodontic treatment.	7 days.	The patients were asked to take an analgesic in the 7 days of time frame.

Trial Locations

Locations (1)

Isparta Military Hospital; 🇹🇷 Isparta, Turkey