NCT04422184

Brief Summary

The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. The evaluation will be in 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Profissional assessments and patient perception data will be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_4

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

Study Start

First participant enrolled

July 29, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

November 28, 2023

Status Verified

May 1, 2023

Enrollment Period

3.8 years

First QC Date

May 29, 2020

Last Update Submit

November 27, 2023

Conditions

Dentin HypersensitivityPeriodontal Diseases

Keywords

root exposureperiodontal treatmentdesensitizing agents.

Outcome Measures

Primary Outcomes (6)

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T1- immediately before scaling and root planing procedures (SRP)

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T2 - immediately after scaling and root planing procedures (SRP)

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T4 - 2 weeks after SRP.

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T5 - 4 weeks after SRP.

  • Professional evaluation of Dentin Hypersensitivity

    Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    T6 - 8 weeks after SRP.

Secondary Outcomes (6)

  • Patient's perception of DH

    T1- immediately before scaling and root planing procedures (SRP)

  • Patient's perception of DH

    T2 - immediately after scaling and root planing procedures (SRP)

  • Patient's perception of DH

    T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.

  • Patient's perception of DH

    T4 - 2 weeks after SRP.

  • Patient's perception of DH

    T5 - 4 weeks after SRP.

  • +1 more secondary outcomes

Study Arms (3)

SEN GROUP

EXPERIMENTAL

Sensodyne Repair and Protect - NOVAMIN technology

Drug: Sensodyne Repair and Protect

REG GROUP

EXPERIMENTAL

Dentalclean Daily Regenerator - REFIX technology

Drug: Dentalclean Daily Regenerator

REGK GROUP

EXPERIMENTAL

Dentalclean Daily Regenerator - REFIX technology + potassium citrate

Drug: Dentalclean Daily Regenerator with potassium citrate

Interventions

Sensodyne Repair and ProtectDRUG

Dentifricie with NOVAMIN technology

Also known as: Dentifrice with desensitizing agents
SEN GROUP
Dentalclean Daily RegeneratorDRUG

Dentifricie with Refix technology

Also known as: Dentifrice with desensitizing agents
REG GROUP
Dentalclean Daily Regenerator with potassium citrateDRUG

Dentifricie with Refix technology+ potassium citrate

Also known as: Dentifrice with desensitizing agents
REGK GROUP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with periodontitis
  • to 70 years old
  • systemically healthy
  • without any allergy to the dentifrices components
  • patients who needed scaling and root planing procedures
  • patients who had at least 2 teeth with DH (incisors, canines or premolars).

You may not qualify if:

  • pregnancy
  • patients in orthodontic treatment
  • patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
  • patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Denstistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (2)

  • West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015 Apr;42 Suppl 16:S256-302. doi: 10.1111/jcpe.12336.

    PMID: 25495777BACKGROUND

  • Patil SA, Naik BD, Suma R. Evaluation of three different agents for in-office treatment of dentinal hypersensitivity: a controlled clinical study. Indian J Dent Res. 2015 Jan-Feb;26(1):38-42. doi: 10.4103/0970-9290.156796.

    PMID: 25961613BACKGROUND

MeSH Terms

Conditions

Dentin SensitivityPeriodontal Diseases

Interventions

DentifricesPotassium Citrate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsCosmeticsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and AgricultureCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Mariana S Ragghianti Zangrando, Prof

    USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 9, 2020

Study Start

July 29, 2019

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

November 28, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)