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

Necrotic Pulp Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05419752
• Other study ID #: ENDO 23/5/2022
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 30, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: Elsayed Hany Elmasry, bsc
• Phone: 00201159536873
• Email: elsayed.hany[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp

Intervention

Drug:
• bioceramic sealer
bioceramic based obturating sealer
• MTA
MTA based obturating sealer
• resin sealer
resin based obturating sealer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of post-operative pain	Measurement of post-operative pain by Visual analogue scale	6 hours
Primary	Intensity of post-operative pain	Measurement of post-operative pain by Visual analogue scale	12 hours
Primary	Intensity of post-operative pain	Measurement of post-operative pain by Visual analogue scale	24 hours
Primary	Intensity of post-operative pain	Measurement of post-operative pain by Visual analogue scale	48 hours
Primary	Intensity of post-operative pain	Measurement of post-operative pain by Visual analogue scale	72 hours
Secondary	post operative swelling	Yes or no yes or no	24 hours