Clincosm LogoSign in Get a demo

Evaluation of Post Operative Pain After Using Two Different Types of Sealers

Sponsor
British University In Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05729893
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers

Condition or Disease Intervention/Treatment Phase
  • Other: root canal sealers
 N/A

Detailed Description

STUDY WILL BE PERFORMED ON PATIENTS DIAGNOSED WITH SYMPTOMATIC IRREVERSABE PULPITIS.

TREATMENT PROTOCOL FOR ALL PATIENTS IS CONVENTIONAL ROOT CANAL TREATMENT

ACCESS CAVITY AND CLEANING AND SHAPING PROCEDURES WILL BE EXECUTED FOR ALL PATIENTS WITH THE SAME PROTOCOL

SELECTED PATIENTS WILL THEN BE DIVIDED INTO TWO GROUPS,

GROUP1: ALL CANALS WILL BE OBTURATED USING RESIN STANDARD SEALERS.

GROUP2: ALL CANALS WILL BE OBTURATED USING HIGH FLOW BIOCERAMIC SEALERS THAT ACCEPT WARM VERTICAL COMPACTION

POST OPERATIVE PAIN IN THE TWO GROUPS WILL BE EVALUATED USING THE VISUAL ANALOUG SCALE AND COMPARED AT DIFFERENT TIME PERIODS (12H, 24H, 48H, 72H)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized clinical trialrandomized clinical trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Patients were randomly divided into two groups according to material used for obturation . each patients name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients care provider and the investigator will not know the name of the patient and the assessor doesn't know the group he is assessing
Primary Purpose:
Treatment
Official Title:
Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: resin group

obturated with resin sealer

Other: root canal sealers
different sealer used in obturating root canals (resin and bio ceramic)
Other Names:
  • bioceramic sealer

    		•
    Active Comparator: bio ceramic group

    obturated with bioceramic sealer

    Other: root canal sealers
    different sealer used in obturating root canals (resin and bio ceramic)
    Other Names:
  • bioceramic sealer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours [12 hours]

      Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    2. Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 24 hours [24 hours]

      Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    3. Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 48 hours [48 hours]

      Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    4. Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 72 hours [72 hours]

      Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • • Patients age ranges from 18-50 years old.

    • Patients with teeth diagnosed with symptomatic irreversible pulpitis.

    • Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space

    • The teeth are restorable

    • Teeth are periodontally free.

    Exclusion Criteria:

    • • Teeth with immature roots

    • Non restorable teeth

    • Medically compromised patients with systemic complication that would alter the treatment.

    • Necrotic teeth

    • Teeth with apical periodontitis or periapical lesions

    • Teeth that need multiple visits treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 British university in egypt Cairo Egypt 02

    Sponsors and Collaborators

    • British University In Egypt

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Alsayed Endo, principal investigator, British University In Egypt
    ClinicalTrials.gov Identifier:
    NCT05729893
    Other Study ID Numbers:
    • BritishUE sara
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Feb 15, 2023