Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607846005228 Date of Registration: 31/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Giomer Varnish, Fluoride Varnish with CPP-ACP or Universal Adhesive System as Desensitizers in Patients with Dentin Hypersensitivity: A Randomized Clinical Trial
Official scientific title Efficacy of Giomer Varnish, Fluoride Varnish with CPP-ACP or Universal Adhesive System as Desensitizers in Patients with Dentin Hypersensitivity: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Dentin hypersensitivity (DH) is a frequently chronic finding and a challenging condition to treat in dental clinical practice. This condition impacts oral health-related quality of life, producing significant impairment on patients’ daily life such as speaking, eating, drinking and toothbrushing. The average prevalence of dentin hypersensitivity reported in cross-sectional studies was estimated to be 33.5% of the population. The treatment of dentin hypersensitivity is by either occluding dentinal tubules or to desensitize pulpal nerve fibers. There are a variety of in-office and over the counter (OTC) products available which are effective in decreasing dentin hypersensitivity. The aim of this study is to assess the efficacy of Giomer varnish as compared to fluoride varnish with CPP-ACP or universal adhesive system to decrease pain over 30 days follow-up period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2026
Actual trial start date
Anticipated date of last follow up 30/10/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 135
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRG Barrier Coat Once (at the start of the trial) Giomer material containing surface prereacted glass ionomer 45
Experimental Group MI varnish Once (at the start of the trial) Fluoride varnish with Casein Phosphopeptide-Amorphous Calcium Phosphate 45
Control Group Futurabond M Once (at the start of the trial) Universal adhesive system 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
I. Participants aged 18 years or above. II. Participants who will be able to provide written informed consent. III. Participants who will be confirmed as healthy by the examiner, without clinically significant diseases that can interfere with the study outcomes. IV. Participants with more than two sensitive teeth with dentin exposure due to gingival recession, abrasion, and erosion I. Individuals who received treatment for dentin hypersensitivity within the past 4 weeks II. Individuals who had teeth with dentin hypersensitivity due to other reasons (e.g., dental caries and defective restorations) III. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the past week IV. Individuals with clinically significant allergic diseases V. Pregnant or lactating women VI. Smokers VII. Individuals who used toothpaste specifically designed for treating dentin hypersensitivity in the past 4 weeks VIII. Individuals who may have undergone teeth bleaching treatment within the past 4 weeks IX. Individuals who underwent scaling or periodontal treatment within the past 4 weeks X. Individuals with teeth that had deep periodontal pockets (> 5 mm) XI. Individuals who underwent cervical restorative treatment (e.g., resin composite and glass ionomer) Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/11/2025 Research Ethics Committee Faculty of Dentistry October 6 University
Ethics Committee Address
Street address City Postal code Country
Part 1/1 - Central Axis 6th of October City - Giza 12585 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Dentin hypersensitivity Baseline, immediately after application of the desensitizing agent, after 7, 15, and 30 days
Primary Outcome Pain reduction Baseline, immediately after application of the desensitizing agent, after 7, 15, and 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Department Faculty of Dentistry October 6 University Part 1/1 - Central Axis 6th October City Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Gamal Abdelwahed Part 1/1 - Central Axis 6th October Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor October 6 University Part 1/1 - Central Axis 6th of October City 12585 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelwahed 152704@o6u.edu.eg +201223710009 Part 1/1 - Central Axis
City Postal code Country Position/Affiliation
6th of October City Egypt Associate Professor of Conservative Dentistry
Role Name Email Phone Street address
Public Enquiries Shereen Fahim shereenessam.dent@o6u.edu.eg +201001816565 Part 1/1 - Central Axis
City Postal code Country Position/Affiliation
6th of October City Egypt Associate Professor of Conservative Dentistry
Role Name Email Phone Street address
Scientific Enquiries Yasmin Ahmed Yasmin.Atef.Dent@o6u.edu.eg +201064555489 Part 1/1 - Central axis
City Postal code Country Position/Affiliation
6th of October City Egypt Lecturer of Conservative Dentistry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Any data will be available upon request. Requests should be directed to152704@o6u.edu.eg and will be sent by email to the requesting party. Data sharing will by anonymous to protect participants' privacy. Available data include informed consent form, raw data and statistical methods. Informed Consent Form After the end of the last follow up (After 30 days) Requests for any data should be directed to152704@o6u.edu.eg and shall not be limited to specific institutes/researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 15/07/2026 It was a typing mistake. Each of the three groups has 45 participants with a total number of 135 60 135
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 25/07/2026 The correct email of the ethics committee was added TRUE, Research Ethics Committee Faculty of Dentistry October 6 University, Part 1/1 - Central Axis , 6th of October City - Giza, 12585, Egypt, , 05 Nov 2025, +201026773131, 152704@o6u.edu.eg, 42593_38906_4737.pdf TRUE, Research Ethics Committee Faculty of Dentistry October 6 University, Part 1/1 - Central Axis , 6th of October City - Giza, 12585, Egypt, , 05 Nov 2025, +201026773131, reco6u@o6u.edu.eg, 42593_38906_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/07/2026 The ethical approval letter was not attached TRUE, Research Ethics Committee Faculty of Dentistry October 6 University, Part 1/1 - Central Axis , 6th of October City - Giza, 12585, Egypt, , 05 Nov 2025, +201026773131, 152704@o6u.edu.eg, TRUE, Research Ethics Committee Faculty of Dentistry October 6 University, Part 1/1 - Central Axis , 6th of October City - Giza, 12585, Egypt, , 05 Nov 2025, +201026773131, 152704@o6u.edu.eg, 42593_38906_4737.pdf