Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
1 other identifier
interventional
54
1 country
1
Brief Summary
PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJune 20, 2018
June 1, 2018
2 months
May 16, 2018
June 8, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Post-operative hypersensitivity at baseline
The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
10 minutes
Post-operative hypersensitivity one week after temporization
The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
1 week
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
1 week
Study Arms (2)
Delayed dentine sealing
ACTIVE COMPARATORImmediate dentin sealing
EXPERIMENTALInterventions
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
Sealing the dentin just prior to cementation
Eligibility Criteria
You may qualify if:
- Extensive carious lesions indicated for indirect restorations
- Lower first molars
- Age of patients range is 18 -50 years
- Patients have not received antibiotic therapy for 1 month before sampling
- Males or Females (Both genders)
- Patients with Good oral hygiene
- Co-operative patients approving the trial
You may not qualify if:
- Pregnancy
- Systemic disease or severe medical
- Patients having complications as:
- Periodontal problems Mobile teeth, arrest caries and non-vital teeth
- Heavy smoking patients
- Xerostomia
- Lack of compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry cairo university
Cairo, 002, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
May 16, 2018
First Posted
June 20, 2018
Study Start
July 1, 2018
Primary Completion
September 1, 2018
Study Completion
October 1, 2018
Last Updated
June 20, 2018
Record last verified: 2018-06