Comparing dental sensitivity after restoring teeth with two novel dental materials

Phase 4

Completed

Conditions: Non Carious Cervical Lesions in mandibular premolar teeth

Registration Number: CTRI/2019/06/019949

Lead Sponsor: Dr Surbhi Gupta

Brief Summary: This study is a randomized controlled clinical trial which will evaluate post operative sensitivity in Non Carious Cervical Lesions restored with Giomer using self etch adhesive and Nanoceramic composite resin using universal adhesive system with self etch and selective enamel etch mode. Mandibular premolars with non carious cervical lesions indicated for restorations will be selected according to the predefined inclusion and exclusion criteria. Sample size of 120 teeth will be selected for the study.They will be divided into 2 main groups A and B and then each group into 2 subgroups.Cavity preparation and restoration will be done. Patients will be kept on a recall period of 24 hours ,1 month,3 months and 6 months. Absence or presence of post operative sensitivity after the defined recall period will serve as the primary outcome of the study whereas intensity of post operative sensitivity will serve as the secondary outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Patients with at least 24 natural teeth 2.Patients having at least 2 contralateral teeth with non carious cervical lesions indicated for restoration 3.Depth of lesions being <1 mm and cervico- occlusal height <2mm 4.Patients willing to participate in study for 6 months 5.Patients with good oral hygiene.

Exclusion Criteria

1.Carious teeth 2.Patients with history of spontaneous pain / sinus tract 3.Patients with class V lesions extending below cemento-enamel junction 4.Patients having parafunctional habits 5.Patients using any desensitizing toothpaste or mouthwash 6.
Patients with active periodontal disease or those who have undergone periodontal surgery during last 6 months 7.Patient allergic to resin based materials 8.Asthmatic patients 9.Patients taking regular NSAIDS, psychotropic drugs or medications for other systemic diseases 10.Pregnant or lactating mothers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients will be evaluated for presence or absence of post operative sensitivity after the defined recall period.	24 hours, 1 month, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Intensity of post operative sensitivity will serve as the secondary outcome for the study. Report from patient regarding dentinal hypersensitivity, air blast test and cold water will be recorded and scored according to Visual Analogue Scale(VAS scale).	24 hours, 1 month, 3 months, 6 months

Trial Locations

Locations (1): J.N Kapoor D.A.V Dental college
🇮🇳
Yamunanagar, HARYANA, India
J.N Kapoor D.A.V Dental college
🇮🇳Yamunanagar, HARYANA, India
Dr Surbhi Gupta
Principal investigator
7500288400
surbhi.gupta.svsu@gmail.com