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Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05419752
Collaborator
(none)
60
Enrollment
3
Arms
1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .

Condition or Disease Intervention/Treatment Phase
  • Drug: bioceramic sealer
  • Drug: MTA
  • Drug: resin sealer
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: endo sequence bioceramic sealer

obturation using Endo-sequence BC sealer

Drug: bioceramic sealer
bioceramic based obturating sealer
Other Names:
  • endosequence

    		•
    Experimental: MTA fill apex calcium silicate base sealer

    obturation using calcium-silicates based MTA fill-apex sealer

    Drug: MTA
    MTA based obturating sealer
    Other Names:
  • MTA fill apex

    		•
    Experimental: AH plus resin sealer

    obturation using AH Plus sealer

    Drug: resin sealer
    resin based obturating sealer
    Other Names:
  • AH Plus resin sealer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intensity of post-operative pain [6 hours]

      Measurement of post-operative pain by Visual analogue scale

    2. Intensity of post-operative pain [12 hours]

      Measurement of post-operative pain by Visual analogue scale

    3. Intensity of post-operative pain [24 hours]

      Measurement of post-operative pain by Visual analogue scale

    4. Intensity of post-operative pain [48 hours]

      Measurement of post-operative pain by Visual analogue scale

    5. Intensity of post-operative pain [72 hours]

      Measurement of post-operative pain by Visual analogue scale

    Secondary Outcome Measures

    1. post operative swelling [24 hours]

      Yes or no yes or no

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients requiring root canal treatment of single canal necrotic teeth.

    • Patient from 18 to 60 years old

    • Patients with Asymptomatic apical periodontitis.

    • Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al

    Exclusion Criteria:

    • Teeth with incompletely formed apex

    • Teeth requiring retreatment

    • Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients

    • Patients taking anti-inflammatory or antibiotics

    • Patients giving history of analgesic or antibiotic intake 1 week before treatment

    • Patients below 18 years of age

    • Patients above 65 years of age

    • Patients having history of peptic ulcer or gastrointestinal bleeding

    • Teeth affected with periodontal disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elsayed Hany Elsayed Attia Elmasry, Master's degree student - faculty of dentistry, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05419752
    Other Study ID Numbers:
    • ENDO 23/5/2022
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Dental Pulp Necrosis
    Necrosis

    Study Results

    No Results Posted as of Jun 15, 2022