Clinical trial NCT04623164: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: complex phytoadaptogenes
periodontitis
periodontal pathogens
microcirculation
Glycyrrhiza glabra
Rhodiola rosea
Acantopanax senticosus
Lead sponsor: Vladikavkaz Scientific Center of the Russian Academy of Sciences
Sponsor class: NETWORK
First posted: 2020-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Periodontal Index Rusell. A.L (1956)
timeFrame: 6 months
measure: Sulcus Bleeding Index Muhleman. H.R (1975) (SBI)
timeFrame: 6 months
Secondary outcomes:
measure: Systolic flow velocity (S)
timeFrame: 6 months
measure: Diastolic flow velocity (D)
timeFrame: 6 months
measure: Medium flow velocity (M)
timeFrame: 6 months
measure: Pulsatory index Gosling (PI)
timeFrame: 6 months
measure: Resistance index (RI)
timeFrame: 6 months
measure: Stuart index (SD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Vladikavkaz
country: Russian Federation
facility: 1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences
state: RSO-Alania
Study officials:
affiliation: Vladikavkaz Scientific Centre of Russian Academy of Sciences
name: Fatima Datieva, M.D.
role: PRINCIPAL_INVESTIGATOR
References: