Complex Phytoadaptogenes in Chronic Periodontitis Treatment.

Vladikavkaz Scientific Center of the Russian Academy of Sciences

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Procedure: Standard non-surgical periodontal treatment (NSPT); Drug: Cocktail from complex phytoadaptogens (CFA)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04623164

Interventional 24.01.2019

Details and patient eligibility

About

A randomized controlled clinical trial was done to assess the periodontal status of the individuals baseline followed by by including chronotherapy with complex phytoadaptogens (CFA) into the non-surgical periodontal treatment (NSPT). The periodontal parameters were again assessed after and compared with the control group (participants with healthy periodontium) and group with non-surgical periodontal treatment (NSPT).

Full description

The aim of this study was to increase the effectiveness of treatment and prevention of chronic generalized periodontitis and increase remission periods by including chronotherapy with complex phytoadaptogens (CFA) into the non-surgical periodontal treatment (NSPT).

Methods: Thirty systemically healthy patients, who had generalized chronic periodontitis with probing pocket depth (PPD) ≥5 mm, plaque index score <1,5 and the ability to maintain optimum oral hygiene after the initial phase of treatment, were included in the present investigation. Patients were divided into 3 groups: 1 Group - control (10 students with healthy periodontium); 2 Group - 10 patients receiving standard non-surgical periodontal treatment (NSPT); 3 Group - CFA application (10 patients receiving NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)). Control examinations were carried out in the following periods: before, after and 6 months after treatment. After each study time point the patients were able to visit the dental office to assess the periodontal status. The examination included the following:

1. Estberg questionnaire to determine the chronotype once before treatment;
2. Simplified Oral Hygiene Index John C. Greene Jack R. Vermillion (1964) (OHI-S);
3. Sulcus Bleeding Index Muhleman. H.R (1975) (SBI);
4. Periodontal Index Rusell. A.L (1956) (PI);
5. Doppler ultrasound. Patients of 2 and 3 groups received oral hygiene instructions (including brushing technique, the use of interdentally flosses, and/or brushes), NSPT (mouth scaling and root planing using an ultrasonic scaler UDS-L LED (Woodpecker, China) and Graceys curettes (Hu Friedy, Chicago, USA)). The treated periodontal pockets were irrigated with 0.12% chlorhexidine gluconate. Patients were given recommendation to rinse their mouth three times daily for 14 days using 0.12% chlorhexidine gluconate Statistical Analysis: Statistical analyses were performed using Statistica 10,0 software ("StatSoft, Inc", Russia). Data were investigated by nonparametric method with determination of median (Md) and interquantile ranges (25th and 75th percentile) due to the small number of variants in the sample (Wilcoxon test). Data were compared before, after and 6 months after treatment. Statistically significant differences in all statistical tests was set to P<0.05.

Enrollment: 30 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• the presence of chronic periodontitis with probing pocket depth (PPD) ≥5 mm, plaque index score <1,5; age from 20-45 years; according to the patients, there is no somatic pathology

Exclusion criteria

• age younger than 20 and older than 45 years; diabetes; chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

1 Group (Control)

No Intervention group

Description:

ten students with healthy periodontium

2 Group

Experimental group

Description:

ten patients receiving standard non-surgical periodontal treatment (NSPT)

Treatment:

Procedure: Standard non-surgical periodontal treatment (NSPT)

3 Group

Experimental group

Description:

ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)

Treatment:

Drug: Cocktail from complex phytoadaptogens (CFA)

Procedure: Standard non-surgical periodontal treatment (NSPT)