Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206703009274 Date of Approval: 15/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative effect of a mouthwash formulated with Spirulina platensis and Chlorhexidine on chronic pariodontitis in patients with cardiovascular disease: a Clinical trials pilot study
Official scientific title Comparative effect of a mouthwash formulated with Spirulina platensis and Chlorhexidine on chronic pariodontitis in patients with cardiovascular disease:
Brief summary describing the background and objectives of the trial Periodontitis is an infectious and inflammatory pathology. Its treatment consists of scaling associated with therapeutic mouthwashes. Current mouthwashes face bacterial resistance, hence the search for growth of natural substances as an alternative. Spirulina platensis is a microalgae whose many properties could be beneficial in the treatment of periodontitis. Our objective was to study the effects of a mouthwash formulated with Spirulina on chronic periodontitis. We conducted a randomized, double-blind, controlled clinical trial on a patient population with CVD and chronic onset periodontitis. Through simple randomization, we formed two groups: Spirulina and Chlorhexidine. Each patient received after scaling, a mouthwash and rinsed the mouth with 15ml of undiluted solution for 60 seconds, twice a day for 30 days. The primary endpoint was the change in periodontal indices. The secondary endpoints were the change in the level of salivary biochemical markers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial oral
Anticipated trial start date 28/03/2021
Actual trial start date 04/04/2021
Anticipated date of last follow up 04/04/2021
Actual Last follow-up date 04/05/2021
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 35
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mouthwash formulated with Spirulina platensis 15ml twice per day, morning and evening 30 days Each patient received after scaling, a mouthwash and rinsed the mouth with 15ml of undiluted solution for 60 seconds, twice a day for 30 days. 18
Control Group Chlorhexidine 15ml of Chlorhexidine twice per day ,morning and evening 30 days Each patient received after scaling, a mouthwash and rinsed the mouth with 15ml of undiluted solution for 60 seconds, twice a day for 30 days. 17 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Adult patients (18 years and older), - men or women with: (1) cardiovascular disease; (2) superficial chronic periodontal inflammation: ≥ 2 inter proximal sites with a loss of attachment ≥ 3mm or ≥2 inter proximal sites with a pocket depth ≥ 4mm (not on the same tooth) or a single site with a depth of pocket ≥ 5mm (CDC-AAP definition of periodontitis); (3) at least 10 teeth in the oral cavity; (4) -All patients gave written informed consent. - Patients lost to follow-up for 7 days; those who have withdrawn their informed consent; -Patients with cardiovascular diseases (CVD) but with moderate / severe chronic periodontitis; patients with CVD at risk of endocarditis: valve disease, valve prosthesis, interventricular communication, persistent aortic duct; patients taking antibiotics, anti-inflammatories, tobacco; or having an allergy to algae; patients using toothpaste or any other medicament with periodontal action including toothpaste based on sodium bicarbonate; and pregnant women. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 68 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/02/2021 The Regional Human Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
NLONGKAC STREET Yaounde 110 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint was the change in periodontal indices Days 15 and days 30
Secondary Outcome The secondary endpoints were the change in the level of salivary biochemical markers , pH, Malondialdehyde, Total Antioxidant Capacity First day and day 30
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Service of Cadiology Yaounde Central Hospital 2 43 68 03 24 Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PIEME CONSTANT ANATOLE TOTAL MELEN Yaounde 1364 Cameroon Individual
Secondary Sponsor Alexia Adorance JOTSA TOTAL MELEN Yaounde 1364 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
CAP Spiruline EMONBO Street Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Constant Anatole PIEME constant.pieme@fmsb-uy1.cm +237674551871 TOTAL MELEN
City Postal code Country Position/Affiliation
Yaounde 1364 Cameroon Faculty of Medicine and Biomedical Sciences University of Yaounde I
Role Name Email Phone Street address
Scientific Enquiries Alexia Adorance JOTSA alexiajotsa1@gmail.com +237656424660 MENDO CITY
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences University of Yaounde I
Role Name Email Phone Street address
Public Enquiries Arnaud CHOUPO arnaudchoupo@yahoo.fr +237695093971 EMANA STREET
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences University of Yaounde I
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) Informed Consent Form Beginning 9 monthsand ending 36 months following article publication To gain access, data requestors will need to sign a data access agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information