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

NCT05419752 | Unknown Phase 2 FDA Drug

• 1 other identifier: ENDO 23/5/2022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Necrotic Pulp; Single Root Teeth

Outcome Measures

Primary Outcomes (5)

• Intensity of post-operative pain

  Measurement of post-operative pain by Visual analogue scale

  6 hours

• Intensity of post-operative pain

  Measurement of post-operative pain by Visual analogue scale

  12 hours

• Intensity of post-operative pain

  Measurement of post-operative pain by Visual analogue scale

  24 hours

• Intensity of post-operative pain

  Measurement of post-operative pain by Visual analogue scale

  48 hours

• Intensity of post-operative pain

  Measurement of post-operative pain by Visual analogue scale

  72 hours

Secondary Outcomes (1)

• post operative swelling

  24 hours

Study Arms (3)

endo sequence bioceramic sealer

EXPERIMENTAL

obturation using Endo-sequence BC sealer

Drug: bioceramic sealer

MTA fill apex calcium silicate base sealer

EXPERIMENTAL

obturation using calcium-silicates based MTA fill-apex sealer

Drug: MTA

AH plus resin sealer

EXPERIMENTAL

obturation using AH Plus sealer

Drug: resin sealer

Interventions

bioceramic sealer DRUG

bioceramic based obturating sealer

Also known as: endosequence

endo sequence bioceramic sealer

MTA DRUG

MTA based obturating sealer

Also known as: MTA fill apex

MTA fill apex calcium silicate base sealer

resin sealer DRUG

resin based obturating sealer

Also known as: AH Plus resin sealer

AH plus resin sealer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

EndoSequence root repair material; Pemetrexed

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Elsayed Hany Elmasry, bsc

CONTACT

00201159536873; elsayed.hany@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student - faculty of dentistry

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 15, 2022
• Study Start: July 30, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06