Complex Phytoadaptogenes in Chronic Periodontitis Treatment.
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Cocktail from complex phytoadaptogens (CFA)
Standard non-surgical periodontal treatment (NSPT)
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Periodontitis focused on measuring complex phytoadaptogenes, periodontitis, periodontal pathogens, microcirculation, Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
Eligibility Criteria
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
Sites / Locations
- 1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
1 Group (Control)
2 Group
3 Group
Arm Description
ten students with healthy periodontium
ten patients receiving standard non-surgical periodontal treatment (NSPT)
ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)
Outcomes
Primary Outcome Measures
Periodontal Index Rusell. A.L (1956)
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.
Sulcus Bleeding Index Muhleman. H.R (1975) (SBI)
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.
Secondary Outcome Measures
Systolic flow velocity (S)
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
Diastolic flow velocity (D)
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
Medium flow velocity (M)
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
Pulsatory index Gosling (PI)
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
Resistance index (RI)
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
Stuart index (SD)
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
Full Information
NCT ID
NCT04623164
First Posted
October 20, 2020
Last Updated
November 3, 2020
Sponsor
Vladikavkaz Scientific Center of the Russian Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04623164
Brief Title
Complex Phytoadaptogenes in Chronic Periodontitis Treatment.
Official Title
Efficacy of Complex Phytoadaptogenes as an Adjunct to Non-surgical Periodontal Treatment in Patients With Chronic Periodontitis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vladikavkaz Scientific Center of the Russian Academy of Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
Estberg questionnaire to determine the chronotype once before treatment;
Simplified Oral Hygiene Index John C. Greene Jack R. Vermillion (1964) (OHI-S);
Sulcus Bleeding Index Muhleman. H.R (1975) (SBI);
Periodontal Index Rusell. A.L (1956) (PI);
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
complex phytoadaptogenes, periodontitis, periodontal pathogens, microcirculation, Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Group (Control)
Arm Type
No Intervention
Arm Description
ten students with healthy periodontium
Arm Title
2 Group
Arm Type
Experimental
Arm Description
ten patients receiving standard non-surgical periodontal treatment (NSPT)
Arm Title
3 Group
Arm Type
Experimental
Arm Description
ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)
Intervention Type
Drug
Intervention Name(s)
Cocktail from complex phytoadaptogens (CFA)
Other Intervention Name(s)
Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard non-surgical periodontal treatment (NSPT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Periodontal Index Rusell. A.L (1956)
Description
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.
Time Frame
6 months
Title
Sulcus Bleeding Index Muhleman. H.R (1975) (SBI)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Systolic flow velocity (S)
Description
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
Time Frame
6 months
Title
Diastolic flow velocity (D)
Description
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
Time Frame
6 months
Title
Medium flow velocity (M)
Description
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
Time Frame
6 months
Title
Pulsatory index Gosling (PI)
Description
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
Time Frame
6 months
Title
Resistance index (RI)
Description
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
Time Frame
6 months
Title
Stuart index (SD)
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Datieva, M.D.
Organizational Affiliation
Vladikavkaz Scientific Centre of Russian Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences
City
Vladikavkaz
State/Province
RSO-Alania
ZIP/Postal Code
362025
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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Complex Phytoadaptogenes in Chronic Periodontitis Treatment.
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