Chronic PeriodontitisPhase 4NCT04623164

Complex Phytoadaptogenes in Chronic Periodontitis Treatment.

A Phase 4 study testing Cocktail from complex phytoadaptogens (CFA) and Standard non-surgical periodontal treatment (NSPT) in people with Chronic Periodontitis, run by Vladikavkaz Scientific Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Periodontitis
What is being tested?: Cocktail from complex phytoadaptogens (CFA) and Standard non-surgical periodontal treatment (NSPT)
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteRussia
Study dates: 1 Feb 2019to 1 Nov 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

Other trials in Russia

About this study

Official title: 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).

Read the 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.

Conditions: Chronic Periodontitis
Being tested: Cocktail from complex phytoadaptogens (CFA), Standard non-surgical periodontal treatment (NSPT)
Keywords: complex phytoadaptogenes, periodontitis, periodontal pathogens, microcirculation, Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
Medical subject headings: Chronic Periodontitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cocktail from complex phytoadaptogens (CFA)Drug
Also called Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
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.
Standard non-surgical periodontal treatment (NSPT)Procedure or surgery
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

Study groups in NCT04623164
Study group	Role	What they receive
1 Group (Control)	No intervention	ten students with healthy periodontium
2 Group	Experimental	ten patients receiving standard non-surgical periodontal treatment (NSPT) Receives: 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) Receives: Drug: Cocktail from complex phytoadaptogens (CFA); Procedure: Standard non-surgical periodontal treatment (NSPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 months

Secondary outcomes (6)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20191 Nov 2019

First posted10 Nov 2020
Study start1 Feb 2019
Primary completion1 May 2019
Study completion1 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04623164
Sponsor's protocol ID: Interventional 24.01.2019
Status last verified: Oct 2020
First submitted: 20 Oct 2020
Last updated: 10 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Complex Phytoadaptogenes as an Adjunct to Non-surgical Periodontal Treatment in Patients With Chronic Periodontitis: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04623164
Acronym / sponsor ID: Interventional 24.01.2019
Conditions: Chronic Periodontitis
Keywords: complex phytoadaptogenes, periodontitis, periodontal pathogens, microcirculation, Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Vladikavkaz Scientific Center of the Russian Academy of SciencesResearch network
Study start: 1 Feb 2019 (actual)
Primary completion: 1 May 2019 (actual)
Study completion: 1 Nov 2019 (actual)
First posted: 10 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1 Group (Control)	No intervention	–ten students with healthy periodontium
2 Group	Experimental	Procedure: Standard non-surgical periodontal treatment (NSPT)ten patients receiving standard non-surgical periodontal treatment (NSPT)
3 Group	Experimental	Drug: Cocktail from complex phytoadaptogens (CFA), Procedure: Standard non-surgical periodontal treatment (NSPT)ten patients receiving standard non-surgical periodontal treatment NSPT + 28-day chronotherapy with complex phytoadaptogens (CFA)

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cocktail from complex phytoadaptogens (CFA)Also: Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosusCocktail 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.	Drug	3 Group
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	Procedure or surgery	2 Group, 3 Group

Primary outcome

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.
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 secondary outcomes

Systolic flow velocity (S)
Time frame: 6 months
Diastolic flow velocity (D)
Time frame: 6 months
Medium flow velocity (M)
Time frame: 6 months
Pulsatory index Gosling (PI)
Time frame: 6 months
Resistance index (RI)
Time frame: 6 months
Stuart index (SD)
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Individual participant dataSharing planned: No

Related trials for Chronic Periodontitis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fatima Datieva, M.D. principal investigator

Vladikavkaz Scientific Centre of Russian Academy of Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal Index Rusell. A.L (1956) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04623164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.