Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses

NCT05354986 | Completed

• 2 other identifiers: 68-07102121/546-EC_X
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Dental staining may interfere with compliance with chlorhexidine mouth rinse use Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Thus, a new anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) has been recently developed, aiming to interfere with the development of extrinsic staining associated with chlorhexidine use (preventive action), but also with the capacity of removing staining already formed. For that, the proposed formulation includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Thus, it may be relevant to test the efficacy of this new anti-staining toothpaste formulation in two consecutive randomized clinical trials (RCTs). Objectives The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).

Conditions

Tooth Staining; Periodontitis

Keywords

Tooth staining; Periodontitis; Chlorhexidine; tripolyphosphate and polyvinylpyrrolidone (PVP)

Outcome Measures

Primary Outcomes (2)

• Tooth Staining

  GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain

  2 weeks

• Tooth Staining

  GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain

  4 weeks

Secondary Outcomes (13)

• Dental plaque

  0 weeks

• Dental plaque

  2 weeks

• Dental plaque

  4 weeks

• Gingival condition

  0 weeks

• Gingival condition

  4 weeks

Study Arms (4)

Control-Control

PLACEBO COMPARATOR

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.

Other: Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)

Control-test

EXPERIMENTAL

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)

Test-control

EXPERIMENTAL

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.

Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)

Test-test

EXPERIMENTAL

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)

Interventions

Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) OTHER

Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Control-test; Test-control; Test-test

Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) OTHER

Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation without tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Control-Control

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.

You may not qualify if:

• Presence of at least three evaluable teeth in each quadrant.
• No orthodontic banding or removable prosthesis.
• Subjects willing to participate and comply with the requirements of the study.
• Acute periodontal conditions.
• Antibiotic intake within the previous month.
• Chronic use of analgesic or anti-inflammatory drugs.
• Pregnant women.
• Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
• Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Dentaid SL: collaborator

Study Sites (1)

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Tooth Discoloration; Periodontitis

Interventions

Toothpastes; hexametaphosphate; triphosphoric acid; Povidone

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances

Study Officials

• David Herrera, Prof.

  Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: test and placebo toothpastes would be identical
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 2, 2022
• Study Start: October 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 9, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)