Complex Phytoadaptogenes in Chronic Periodontitis Treatment.

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623164
• Other study ID #: Interventional 24.01.2019
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2020
• Source: Vladikavkaz Scientific Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

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

Locations

Country	Name	City	State
Russian Federation	1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences	Vladikavkaz	RSO-Alania

Sponsors (1)

Lead Sponsor	Collaborator
Vladikavkaz Scientific Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months