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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04789343
Other study ID # SAG-C-DUP-170419-0144
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2020
Est. completion date December 29, 2020

Study information

Verified date March 2021
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: The aim of this study was to assess postoperative pain in prospective randomized clinical trial comparing Reciproc or hand instrument and also different obturation techniques in one visit of endodontic retreatment. Conventional root canal treatment was done to 45 patients who needed retreatment. All instruments used in this study are routinely used instrument in endodontic therapy. After completed root canal treatment, the patients asked the intense of post operative pain.


Description:

Materials and metods: The study was included 45 patients (18-65 yrs old) who needed endodontic retreatment in mandibular premolar or molar without any symptoms. The teeth had been randomly assign into 3 groups according to the instrumentation or obturation techniques; hand files with lateral condensation, Reciproc with lateral condensation, or Reciproc with continuous condensation technique. Retreatments had performed in a single visit. Coronal restorations were removed, the gutta-percha were extracted using either Reciproc or hand files. After, biochemical and mechanical praparation, the canals were filled with gutta-percha cones and AH Plus sealer using the lateral condensation or continuous wave of obturation technique. Participants were been asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24h, 48h and 72h and 7 days after retreatment. All data were analyzed using (Chi-square test, p=0,05)


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 29, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - patients who had previosly done unacceptable root canal treatment on lower premolar or molar with no pain. No medication should be taken 10 days before treatment for any reason ( such as corticosteroid, antibiotics or analgesic ) Exclusion Criteria: - age less than 18 or over 65,pregnancy nonrestorable tooth other than lower molar or premolar tooth with more than 4mm periodontal pocket root with broken instrument or any post

Study Design


Intervention

Other:
Root canal treatment
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.

Locations

Country Name City State
Turkey Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Post operative pain; change is being assessed. VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic 72 hours.
Other post operative pain; change is being assessed. VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic 7 days.
Primary Post operative pain VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic 24 hours.
Secondary Post operative pain; change is being assessed. VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic 48 hours
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