Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash

March 14, 2024 updated by: Andrea Scribante, University of Pavia

Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash: Randomized Clinical Trial

The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.

At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).

Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.

Subsequently, patients will be randomly divided into two groups:

- the Trial group, in which patients will perform home oral hygiene with Emoform Glic toothpaste + mouthwash twice a day the Control group, in which patients will perform home oral hygiene with Emoform Glic toothpaste twice a day.

Professional debridement will be repeated every 3 months. Periodontal indexes evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women at the 4th month of pregnancy

Exclusion Criteria:

  • presence of cardiac pacemaker
  • neurological and psychiatric diseases
  • patients taking bisphosphonates during the previous 12 months from the - beginning of the study
  • patients undergoing anticancer therapy.
  • patients with poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: Emoform Glic Toothpaste
Daily use of Emoform Glic toothpaste twice a day during home oral hygiene
Experimental: Trial group
Other: Emoform Glic Toothpaste
Daily use of Emoform Glic toothpaste twice a day during home oral hygiene
Other: Emoform Glic Mouthwash
Daily use of Emoform Glic mouthwash twice a day during home oral hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plaque Index (Silness and Loe, 1964)
Time Frame: Baseline, 1, 3 and 6 months

Scoring criteria:

0 = no plaque;

  1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe;
  2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye;
  3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Baseline, 1, 3 and 6 months
Change in Recession (R)
Time Frame: Baseline, 1, 3 and 6 months
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Baseline, 1, 3 and 6 months
Change in Clinical Attachment Loss (CAL)
Time Frame: Baseline, 1, 3 and 6 months
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Baseline, 1, 3 and 6 months
Change in Bleeding on Probing (BoP)
Time Frame: Baseline, 1, 3 and 6 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 6 sites.

Percentage of sites with bleeding on probing determines the BOP%.
Baseline, 1, 3 and 6 months
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, 1, 3 and 6 months
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Baseline, 1, 3 and 6 months
Change in Plaque Control Record (PCR%)
Time Frame: Baseline, 1, 3 and 6 months
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Baseline, 1, 3 and 6 months
Change in Papillary Marginal Gingival Index (PMGI)
Time Frame: Baseline, 1, 3 and 6 months
Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
Baseline, 1, 3 and 6 months
Change in modified Marginal Gingival Index (mMGI)
Time Frame: Baseline, 1, 3 and 6 months

Scoring criteria:

0 = Absence of inflammation

  1. = Mild inflammation (marginal or papillary unit)
  2. = Mild inflammation (entire marginal and papillary unit)
  3. = Moderate inflammation
  4. = Severe inflammation
Baseline, 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-LACTOFERRINPREGNANT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available upon motivated request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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