Foraminal Enlargement and Postoperative Pain.

Isparta Military Hospital

Status and phase: Completed; Phase 1

Conditions: Pain Postoperative

Treatments: Procedure: Foraminal enlargement

Study type: Interventional

Funder types: Other

Identifiers

NCT02770053

IAH-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: Foraminal enlargement

Control

Active Comparator group

Description:

In the control group, no foraminal enlargement will be performed.

Treatment:

Procedure: Foraminal enlargement