Comparison of the Effectiveness of Self Etch Adhesive and Fluoride Varnish in Reducing Hypersensitivity in Patients With Gingival Recession

NCT05895526 | Unknown

• 1 other identifier: PDC
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial ABSTRACT Objective: To compare the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession Study Design: Randomized Clinical Trial Place of Study: Department of Operative Dentistry and Endodontics, Peshawar Dental College, Warsak Road. Methodology: 142 diagnosed cases of Dentin hypersensitivity from outpatient department of nephrology, Prime Hospital Peshawar will be referred to operative department, Peshawar dental college for Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. Results: Conclusion:

Conditions

Dentin Sensitivity

Keywords

Dentin permeability; Dentin hypersensitivity; Gingival recession

Outcome Measures

Primary Outcomes (1)

• Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial

  Patients will be divided into two groups. The Group 1 will receive the treatment that is based on the fluoride varnish company's instruction whereas Group 2 patients will under treatment regimens based on self etch dentin adhesive company's instructions.A clinical evaluation of each tooth will be done by another investigator who will not be involved with the treatment procedure. Air stimulation response measurement will be done via Visual analogue scale with score 0( No pain) ,1 2 3 ( Mild pain) , 4 5 6 (Moderate Pain) , 7 8 9 10 (Severe pain).The baseline evaluation (T0) before intervention , on the day of intervention after application of agents(T1), after one week (T2) and one month after treatment (T3) using tactile and air blast stimuli.The same examiner will calculate the total Visual analogue scale score of each study group at each follow up time from the mean of Visual analogue scale scores of all treated teeth of every subject in the same group..

  Two months

Study Arms (2)

5% Sodium Fluoride Varnish

EXPERIMENTAL

71 patients will be in 5% Sodium Fluoride Varnish

Procedure: Self etch dentin adhesive, Fluoride varnish

Self Etch Dentin Adhesive

EXPERIMENTAL

71 patients will be in Self Etch Dentin Adhesive

Procedure: Self etch dentin adhesive, Fluoride varnish

Interventions

Self etch dentin adhesive, Fluoride varnish PROCEDURE

After an informed consent, in one group 5% sodium fluoride varnish will be applied in affected area, while the other group will receive self etch dentin adhesive.

5% Sodium Fluoride Varnish; Self Etch Dentin Adhesive

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with dentin hypersensitivity due to gingival recession.
• Patients having Miller's Class 1 gingival recession.
• Patient aged between 20-45yrs with gingival recession without other periodontal issues.
• Patient without root filled teeth.
• Patients who are willing to participate in the study.

You may not qualify if:

• Teeth with extensive gingival recession.
• Teeth with cervical restoration.
• Pregnant and lactating mother.
• Crowned teeth.

Sponsors & Collaborators

• Prime Foundation: lead

Study Sites (1)

Peshawar Dental College

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Dentin Sensitivity; Gingival Recession

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy

Study Officials

• Rizwan Qureshi, BDS, FCPS

  Peshawar Dental College

  STUDY CHAIR

Central Study Contacts

Iftikhar Akbar, FCPS, CHPE

CONTACT

00923479368676; driftikhar156@hotmail.com

Sobia Owais, BDS

CONTACT

sohakhan9541@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. Group A (Application of 5% sodium fluoride varnish) 2. Group B (Self etch dentin adhesive)

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: June 8, 2023
• Study Start: June 12, 2023
• Primary Completion: August 12, 2023
• Study Completion: August 12, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

PA (1)