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

U

University of Pavia

Status

Invitation-only

Conditions

Periodontal Diseases

Treatments

Other: Emoform Glic Mouthwash
Other: Emoform Glic Toothpaste

Study type

Interventional

Funder types

Other

Identifiers

NCT06311253
2024-LACTOFERRINPREGNANT

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Trial group
Experimental group
Treatment:
Other: Emoform Glic Toothpaste
Other: Emoform Glic Mouthwash
Control group
Active Comparator group
Treatment:
Other: Emoform Glic Toothpaste

Trial contacts and locations

1

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Central trial contact

Andrea Scribante, DDS, PhD

Data sourced from clinicaltrials.gov

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