Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations

Hypersensitivity Dentin Clinical Trial

Official title:

Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03562858
• Other study ID #: CEBD-CU-2018-05-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: October 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: Hoda Fouda, Master
• Phone: 01003786531
• Email: Hoda.omar[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity Dentin

Intervention

Procedure:
• Immediate dentin sealing protocol
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
• Delayed dentin sealing protocol
Sealing the dentin just prior to cementation

Locations

Country	Name	City	State
Egypt	Faculty of dentistry cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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