Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health

Periodontal Diseases Clinical Trial

Official title:

Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400538
• Other study ID #: 2022-PREGNANCY
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: December 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

• Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day

• Control group: home oral application of Biorepair Peribioma Toothpaste

Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.

Description:

The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

• Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day

• Control group: home oral application of Biorepair Peribioma Toothpaste

Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• Biorepair Toothpaste + Mousse
Domiciliary application of the products twice a day.
• Biorepair Toothpaste
Domiciliary application of the product twice a day.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PPD - Probing Pocket Depth	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, after 1, 3 and 6 months.
Primary	Change in BOP - Bleeding on Probing (percentage)	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, after 1, 3 and 6 months.
Primary	Change in CAL - Clinical Attachment Loss	Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).	Baseline, after 1, 3 and 6 months.
Primary	Change in R - Gingival recession	Distance (in mm) between the gingival margin and the amelo-cemental junction.	Baseline, after 1, 3 and 6 months.
Primary	Change in PCR% - Plaque Control Record	% 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, after 1, 3 and 6 months.
Primary	Change in MGI - Modified Gingival Index	Scoring criteria: 0: normal; 1: mild inflammation (slight changes in color and texture, but not in all portions of gingival marginal or papillary); 2: mild inflammation (slight changes in color and texture in all portions of gingival marginal or papillary); 3: moderate (bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary); 4: severe inflammation (erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration)	Baseline, after 1, 3 and 6 months.
Primary	Change in PMGI - Papillary Marginal Gingival Index	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, after 1, 3 and 6 months.