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A New Protocol for the Management of Dental Erosion in Rugby Players

Sponsor
University of Pavia (Other)
Overall Status
Completed
CT.gov ID
NCT05140538
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4.4
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards. Patients selected for the study will be randomly divided and allocated in two groups according to the treatment:

  • Group 1: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day

  • Group 2: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

Condition or Disease Intervention/Treatment Phase
  • Other: SRP + toothpaste + mouthwash
  • Other: SRP + toothpaste
 N/A

Detailed Description

The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards and to prevent further worsening of dental erosion. Patients selected for the study will sign the informed consent and will be randomly divided and allocated into two groups:

  • Group 1: SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day

  • Group 2: SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in

  1. for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A New Domiciliary Oral Care Protocol for the Management of Dental Erosion in Rugby Players: A Randomized Clinical Trial
Actual Study Start Date :
Dec 18, 2021
Actual Primary Completion Date :
Apr 27, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day

Other: SRP + toothpaste
Use of domiciliary products twice a day
Experimental: Group 2

SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Other: SRP + toothpaste + mouthwash
Use of domiciliary products twice a day

Outcome Measures

Primary Outcome Measures

  1. Change in BOP - Bleeding on Probing (percentage) [Study begin, 1 and 3 months]

    Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual).

  2. Change in Schiff Air Index - Dental sensitivity test [Study begin and after 15, 30 and 90 days.]

    Scoring criteria: 0: the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.

  3. Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008) [Study begin and after 15, 30 and 90 days.]

    Scoring criteria: 0: no erosive tooth wear; initial loss of surface texture; distinct defect, hard tissue loss < 50% of the surface area; hard tissue loss ≥ 50% of the surface area.

  4. Change in PI - Plaque Index (percentage) [Study begin and after 15, 30 and 90 days.]

    Evaluation of the presence of plaque with a disclosing agent on the 4 surfaces of teeth on the total amount of dental surfaces multiplied per 100.

  5. Dental sensitivity [Study begin and after 15, 30 and 90 days.]

    Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients willing to participate to the study

  • Rugby players

Exclusion Criteria:

  • Patients with cardiac pacemaker

  • Patients suffering from neurological disorders

  • Patients suffering from psychological disorders

  • Pregnant or breastfeeding women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia Pavia Lombardy Italy 27100

Sponsors and Collaborators

  • University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Scribante, Research Resident, Principal Investigator, University of Pavia
ClinicalTrials.gov Identifier:
NCT05140538
Other Study ID Numbers:
  • 2021-RUGBY
First Posted:
Dec 1, 2021
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Scribante, Research Resident, Principal Investigator, University of Pavia
enamel remineralization
Additional relevant MeSH terms:
Tooth Erosion

Study Results

No Results Posted as of May 12, 2022