NCT04472182

Brief Summary

This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

July 11, 2020

Last Update Submit

January 20, 2022

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (6)

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    Two minutes before intervention

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    4 hours

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    2 days

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    4 months

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    8 months

  • Pain due to Dentin Hypersensitivity

    Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale

    12 months

Secondary Outcomes (12)

  • Measuring Salivary pH

    Two minutes before intervention

  • Measuring Salivary pH

    4 hours

  • Measuring Salivary pH

    2 days

  • Measuring Salivary pH

    4 months

  • Measuring Salivary pH

    8 months

  • +7 more secondary outcomes

Study Arms (2)

Fluoride varnish with xylitol coated calcium and phosphate

EXPERIMENTAL
Drug: Fluoride varnish with xylitol coated calcium and phosphate

Conventional Fluoride varnish

ACTIVE COMPARATOR
Drug: Fluoride varnish with xylitol coated calcium and phosphate

Interventions

Fluoride varnish with xylitol coated calcium and phosphateDRUG

Fluoride varnish with xylitol coated calcium and phosphate

Conventional Fluoride varnishFluoride varnish with xylitol coated calcium and phosphate

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study

You may not qualify if:

  • Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS \<5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo U

Giza, 12311, Egypt

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Phosphates

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsAnionsIonsElectrolytesPhosphorus Compounds

Study Officials

  • Peter E Abdelmalik, Master

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Dentin Hypersensitivity
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 11, 2020

First Posted

July 15, 2020

Study Start

December 20, 2020

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

EG(1)