Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363721
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-09
Brief Title:
A Pilot Study of a Commercially-available Oil Rinse Product PerioPull on Markers of Dental Health
Sponsor:
Designs for Health
Organization:
Designs for Health
Study Overview
Official Title:
A Pilot Study of a Commercially-available Oil Rinse Product PerioPull on Markers of Dental Health
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product PerioPull on parameters of dental health among a sample of adults PerioPull is commercially available and sold primarily from clinicians offices
A 12-week pilot study will be conducted to achieve the purpose of this study The research team hypothesizes that PerioPull will improve a variety of validated markers of dental health that are commonly used in clinical practice
A 12-week pilot study will be conducted to achieve the purpose of this study The research team hypothesizes that PerioPull will improve a variety of validated markers of dental health that are commonly used in clinical practice
Detailed Description:
Patients that suffer from dental health issues often have a deeper than normal pocket depth These pockets can become filled with infection causing bacteria causing inflammation around the tooth leading to periodontal disease
The current recommendations are to brush with Sensodyne use a special mouthwash do not brush as hard or use an electric toothbrush
PerioPull is a natural oil rinse formula to support overall oralgum health tooth stains and natural teeth whitening This formula contains specific nutrients that have been previously studied and shown to be efficacious in oral health These actions do not have any known side effects which present an advantage over standard dental treatments with fluoride chlorhexidine hydrogen peroxide and other chemicals
This oil rinse formula is a commercially available product sold primarily from physicians offices As indicated in the ingredient list provided below PerioPull includes Medium Chain Triglycerides C8 C10 C12 from coconut oil Bixa orellana Annatto Seed Extract GG-Gold Natural Mint Flavor Bromelain Ubiquionone Delta Tocotrienols
The proposed study is a 12-week pilot study of PerioPull Eligible participants will be recruited from within the clinical practice of the periodontist
Study outcomes will consist of parameters of dental health among a sample of adults These outcomes will be collected during a dental visit and assessed at baseline six weeks and at the conclusion of the 12-week clinical trial
Oral samples that are obtained during clinical visits will be sent to lab utilized by participating clinical practices for analysis of study outcomes
The outcomes in this clinical trial have been studied in previous clinical trials among dental patients One oral sample at each of the three study visits is all that is required to collect outcomes
All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart These are typical assessments in routine clinical practice
The current recommendations are to brush with Sensodyne use a special mouthwash do not brush as hard or use an electric toothbrush
PerioPull is a natural oil rinse formula to support overall oralgum health tooth stains and natural teeth whitening This formula contains specific nutrients that have been previously studied and shown to be efficacious in oral health These actions do not have any known side effects which present an advantage over standard dental treatments with fluoride chlorhexidine hydrogen peroxide and other chemicals
This oil rinse formula is a commercially available product sold primarily from physicians offices As indicated in the ingredient list provided below PerioPull includes Medium Chain Triglycerides C8 C10 C12 from coconut oil Bixa orellana Annatto Seed Extract GG-Gold Natural Mint Flavor Bromelain Ubiquionone Delta Tocotrienols
The proposed study is a 12-week pilot study of PerioPull Eligible participants will be recruited from within the clinical practice of the periodontist
Study outcomes will consist of parameters of dental health among a sample of adults These outcomes will be collected during a dental visit and assessed at baseline six weeks and at the conclusion of the 12-week clinical trial
Oral samples that are obtained during clinical visits will be sent to lab utilized by participating clinical practices for analysis of study outcomes
The outcomes in this clinical trial have been studied in previous clinical trials among dental patients One oral sample at each of the three study visits is all that is required to collect outcomes
All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart These are typical assessments in routine clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None