Complex Phytoadaptogenes in Chronic Periodontitis Treatment.

November 3, 2020 updated by: Vladikavkaz Scientific Center of the Russian Academy of Sciences

Efficacy of Complex Phytoadaptogenes as an Adjunct to Non-surgical Periodontal Treatment in Patients With Chronic Periodontitis: a Randomized Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • RSO-Alania
      • Vladikavkaz, RSO-Alania, Russian Federation, 362025
        • 1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1 Group (Control)
ten students with healthy periodontium
Experimental: 2 Group
ten patients receiving standard non-surgical periodontal treatment (NSPT)
Procedure: Standard non-surgical periodontal treatment (NSPT)
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
Experimental: 3 Group
ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)
Procedure: Standard non-surgical periodontal treatment (NSPT)
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
Drug: Cocktail from complex phytoadaptogens (CFA)
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.
Other Names:
  • Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal Index Rusell. A.L (1956)
Time Frame: 6 months

Changes in clinical parameter PI (Periodontal Index Rusell. A.L (1956)) in chronic periodontitis patients of group 2 (with NSPT) and group 3 (NSPT + 28-day use of CFA) from baseline to 6 months.

Index shows severity of gingivitis, the presence of periodontal pockets, tooth mobility and alveolar bone loss. Evaluation of results: 0.1 - 1.5 points - I stage; 1.5 - 4.0 points - stage II; 4.0 - 8.0 points - stage III.
6 months
Sulcus Bleeding Index Muhleman. H.R (1975) (SBI)
Time Frame: 6 months

Changes in clinical parameter SBI (Sulcus Bleeding Index Muhleman. H.R (1975)) in chronic periodontitis patients of group 2 (with NSPT) and group 3 (NSPT + 28-day use of CFA) from baseline to 6 months.

Index is used for assessment of gingival bleeding. Evaluation of results: score 0 - gingival of normal texture and color, no bleeding; score 1 - gingival apparently normal, bleeding on probing; score 2 - bleeding on probing, change in color, no oedema; score 3 - bleeding on probing change in color, slight oedema; score 4 - either: (a) bleeding on probing, change in color, obvious oedema; or (b) bleeding on probing, obvious oedema; score 5 - bleeding on probing and spontaneous bleeding, change in color, marked oedema.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic flow velocity (S)
Time Frame: 6 months
Systolic flow velocity (S) (Vad, mm/sec) was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months
Diastolic flow velocity (D)
Time Frame: 6 months
Diastolic flow velocity (D) (Vad, mm/sec) was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months
Medium flow velocity (M)
Time Frame: 6 months
Medium flow velocity (M) (Vad, mm/sec) was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months
Pulsatory index Gosling (PI)
Time Frame: 6 months
Pulsatory index Gosling (PI) (relevant units) - reflects the elastic properties of the arteries; was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months
Resistance index (RI)
Time Frame: 6 months
Resistance index (RI) (relevant units) - reflects the state of blood flow resistance distal to the measurement site; was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months
Stuart index (SD)
Time Frame: 6 months
Stuart index (SD) (relevant units) - reflects the elastic properties of the arteries; was investigated by Doppler ultrasound in chronic periodontitis patients of group 2 (with non-surgical periodontal therapy (NSPT)) and group 3 (NSPT + 28-day use of complex phytoadaptogens (CFA)) from baseline to 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vladikavkaz Scientific Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Fatima Datieva, M.D., Vladikavkaz Scientific Centre of Russian Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional 24.01.2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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