FE in Anterior Teeth

NCT03527602 | Unknown

• 1 other identifier: IAH-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Apical Periodontitis

Keywords

Apical patency; Endodontics

Outcome Measures

Primary Outcomes (1)

• 100-mm Visual Analog Scale (VAS).

  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)

  5 days

Secondary Outcomes (1)

• The number of patients taking an analgesic following the endodontics treatment.

  5 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: Foraminal enlargement

Control

NO INTERVENTION

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

Interventions

Foraminal enlargement PROCEDURE

After determining the working length, a rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isparta Military Hospital: lead

Study Sites (1)

Isparta Military Hospital

Isparta, 32010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• ibrahim ethem yaylali

  Military Hospital, Isparta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ibrahim Ethem Yaylali, PhD

CONTACT

05378707924; ibotenring@yahoo.com

ibrahim E Yaylali, PhD

CONTACT

05378707924; ibotenring@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind. (Participants)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dentistry

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 17, 2018
• Study Start: November 5, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 5, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-06

Locations

TU (1)