Complex Phytoadaptogenes in Chronic Periodontitis Treatment.

NCT04623164 | Completed Phase 4 DMC

• 1 other identifier: Interventional 24.01.2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Periodontitis

Keywords

complex phytoadaptogenes; periodontitis; periodontal pathogens; microcirculation; Glycyrrhiza glabra; Rhodiola rosea; Acantopanax senticosus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Systolic flow velocity (S)

  6 months

• Diastolic flow velocity (D)

  6 months

• Medium flow velocity (M)

  6 months

• Pulsatory index Gosling (PI)

  6 months

• Resistance index (RI)

  6 months

Study Arms (3)

1 Group (Control)

NO INTERVENTION

ten students with healthy periodontium

2 Group

EXPERIMENTAL

ten patients receiving standard non-surgical periodontal treatment (NSPT)

Procedure: Standard non-surgical periodontal treatment (NSPT)

3 Group

EXPERIMENTAL

ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)

Drug: Cocktail from complex phytoadaptogens (CFA); Procedure: Standard non-surgical periodontal treatment (NSPT)

Interventions

Cocktail from complex phytoadaptogens (CFA) DRUG

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.

Also known as: Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus

3 Group

Standard non-surgical periodontal treatment (NSPT) PROCEDURE

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

2 Group; 3 Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vladikavkaz Scientific Center of the Russian Academy of Sciences: lead

Study Sites (1)

1Institute of Biomedical Investigations - the Affiliate of Vladikavkaz Scientific Centre of Russian Academy of Sciences

Vladikavkaz, RSO-Alania, 362025, Russia

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Glycyrrhiza glabra extract

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatima Datieva, M.D.

  Vladikavkaz Scientific Centre of Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 10, 2020
• Study Start: February 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)