Trials Sponsors Conditions Drugs Pricing

Conditions

Black Stains

Keywords

Oral microbiotaPeriodontal bacteria

Outcome Measures

Primary Outcomes (1)

Change in the extension of black stains (Gasparetto et al., 2003)
Scoring criteria: * 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin; * 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface; * 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface
Study begin, 2 and 6 months.

Secondary Outcomes (3)

Change in DMFT (Decayed Missing Filled Teeth) score
Study begin, 2 and 6 months.
Change in DMFS (Decayed Missing Filled Surfaces) score
Study begin, 2 and 6 months.
Dietary habits
Study begin, 2 and 6 months.

Study Arms (3)

Group 1

EXPERIMENTAL

Patients will use products based on lactoferrin.

Other: Lactoferrin products

Probiotics

EXPERIMENTAL

Patients will use products based on probiotics for home oral care.

Other: Probiotics products

Standard therapy

ACTIVE COMPARATOR

Patients will use standard toothpastes for home oral care.

Other: Standard home oral care

Interventions

Lactoferrin productsOther

Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.

Group 1

Probiotics productsOther

Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.

Probiotics

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients with black stains
Patients with high compliance

You may not qualify if:

Sponsors & Collaborators

University of Pavia
Otherlead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Study Officials

Andrea Scribante, DDS, PhD.
University of Pavia
PRINCIPAL INVESTIGATOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Research Resident, Principal Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

May 15, 2021

Actual (reported)

Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Group 1

Probiotics

Standard therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Group 1

Probiotics

Standard therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations