NCT04340869

Brief Summary

Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

March 2, 2020

Last Update Submit

April 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale pain score

    0 = no pain to 10=severe exagerated pain

    1 month

Study Arms (3)

Theobromine

EXPERIMENTAL

Natural extract from Cocoa

Other: Theobromine

Remin Pro

ACTIVE COMPARATOR

Fluoride , Hydroxyapatite , and Xylitol

Other: Remin Pro

Combination

EXPERIMENTAL

Remin Pro and Theobromine

Other: TheobromineOther: Remin Pro

Interventions

Natural extract from Cocoa

CombinationTheobromine

Remin Pro

CombinationRemin Pro

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients that aged 18-50 years.
  • Patients in good general health.
  • Patients that have accessible teeth demonstrating signs of sensitivity.

You may not qualify if:

  • Any chronic debilitating disease that could influence study outcomes.
  • Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
  • Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
  • Desensitising treatment or tooth bleaching within 8 weeks of screening.
  • Daily use of medications that might influence the perception of pain.(

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University , Faculty of Dental medicine for Girls

Cairo, 11111, Egypt

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Theobromine

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2020

First Posted

April 10, 2020

Study Start

August 1, 2019

Primary Completion

August 1, 2021

Study Completion

April 1, 2022

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Locations