Postoperative Pain and PTN and Reciproc

NCT03380585 | Completed DMC

• 1 other identifier: IAH-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper Next) on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc) and rotational multi-file system (ProTaper Next).

Conditions

Apical Periodontitis; Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (1)

• 4-step pain intensity measures using a Visual Analog Scale (VAS).

  The severity of pain in 1-7 days according to the VAS: 0 no pain, 1-3 mild pain, 4-7 moderate pain, 7-10 severe pain.

  7 days

Secondary Outcomes (1)

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

  7 days

Study Arms (2)

Reciproc

EXPERIMENTAL

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. 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. In this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc single-file system. The intervention is foraminal enlargement with the Reciproc single-file system.

Procedure: Reciprocating single-file system

ProTaper Next

ACTIVE COMPARATOR

The active comparator is foraminal enlargement with the ProTaper Next multi-file system. Endodontic treatment is identical to experimental group except file systems used. In this group, ProTaper Next multi-file system will be used in enlarging apical foramina.

Procedure: Rotational multi-file system.

Interventions

Reciprocating single-file system PROCEDURE

After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.The device in the experimental group moves in CW and CCW direction with different angles. It is a single-file endodontic file system. The intervention is reciprocating single-file system. A Reciproc single-file will be used for enlarging apical foramen. In the active comparator group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.

Also known as: Reciproc

Reciproc

Rotational multi-file system. PROCEDURE

After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. In this group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.

Also known as: ProTaper Next

ProTaper Next

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.

You may not qualify if:

• Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.

Sponsors & Collaborators

• Isparta Military Hospital: lead

Study Sites (1)

Isparta Military Hospital

Isparta, 32010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ibrahim E YAYLALI, PhD

  Isparta Military Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 21, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 2, 2018
• Last Updated: March 12, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)