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

Not Applicable

• Conditions: Periodontal Diseases
• Interventions: Other: Emoform Glic Toothpaste; Other: Emoform Glic Mouthwash

• Registration Number: NCT06311253
• Lead Sponsor: University of Pavia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Study Start: 2024-03-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial group	Emoform Glic Toothpaste	-
Control group	Emoform Glic Toothpaste	-
Trial group	Emoform Glic Mouthwash	-

Primary Outcome Measures

Name	Time	Method
Change in Plaque Index (Silness and Loe, 1964)	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.
Change in Bleeding on Probing (BoP)	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%.
Change in modified Marginal Gingival Index (mMGI)	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
Change in Clinical Attachment Loss (CAL)	Baseline, 1, 3 and 6 months	Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in Recession (R)	Baseline, 1, 3 and 6 months	Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in Probing Pocket Depth (PPD)	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.
Change in Papillary Marginal Gingival Index (PMGI)	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.
Change in Plaque Control Record (PCR%)	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.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy