Post-operative Sensitivity in Resin Composites

Caries,Dental Clinical Trial

Official title:

Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06242184
• Other study ID #: NAMIR
• Status: Completed
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: February 2024
• Source: Pakistan Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Description:

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participants with goof general health status

• Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.

• Vital and Periodontally sound teeth

Exclusion Criteria:

• Patient with Temporomandibular dysfunction

• History of spontaneous pain

• Endodontically treated teeth

• Patient on analgesics within the past two weeks

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries
• Dentin Sensitivity
• Hypersensitivity
• Sensitivity, Tooth

Intervention

Procedure:
• Group A(Nano-fortified Adhesive)
Nano-fortified dentin adhesive
• Group B(Adhesive without nanoparticles)
Conventional adhesives without nanoparticles

Locations

Country	Name	City	State
Pakistan	School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative sensitivity	Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)	One month