Complex Phytoadaptogenes in Chronic Periodontitis Treatment.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed 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.
    

Intervention name(s): Cocktail from complex phytoadaptogens (CFA); Standard non-surgical periodontal treatment (NSPT)
Intervention type(s): Drug; Procedure
Intervention description(s): Cocktail from complex phytoadaptogens (CFA) is composed from 70% alcohol extracts of Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus in the ratio 2:1:1. Application of CFA in 3 group was carried out after non-surgical periodontal therapy (NSPT). After NSPT the patient filled out an Estberg questionnaire to determine the chronotype. After processing the questionnaire, a chronotype was identified and the patient was prescribed CFA dosage. Application of CFA was carried out in the periods of exacerbation of chronic periodontitis within 28 days with a dosage of CFA depending on the chronotype of the person - morning chronotype at 45 drops in the morning before 10.00 o'clock; independent chronotype 20 drops 3 times a day; evening chronotype 30 drops at 14.00 o'clock and 20 drops at 19.00 o'clock.; 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
Other intervention name(s): Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: complex phytoadaptogenes; periodontitis; periodontal pathogens; microcirculation; Glycyrrhiza glabra; Rhodiola rosea; Acantopanax senticosus