Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514664
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This controlled randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data
The main questions it aims to answer are
Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers
The study includes four groups Group 1 Use of probiotic toothpaste smoking patient Group 2 Use of regular toothpaste smoking patient Group 3 Use of probiotic toothpaste non-smoking patient Group 4 Use of regular toothpaste non-smoking patient
The main questions it aims to answer are
Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers
The study includes four groups Group 1 Use of probiotic toothpaste smoking patient Group 2 Use of regular toothpaste smoking patient Group 3 Use of probiotic toothpaste non-smoking patient Group 4 Use of regular toothpaste non-smoking patient
Detailed Description:
Periodontitis is characterized by the progressive destruction of all periodontium structures that support the teeth including periodontal connective tissue and alveolar bone caused by dental biofilm resulting in irreversible damage Severe periodontitis has become a public health problem that affects approximately 11 of the worlds population that is 743 million people When left untreated it reduces the quality of life and leads to tooth loss In addition to being a common cause of tooth loss severe periodontitis has been reported to be a predisposing factor in the development of major systemic diseases such as atherosclerosis cerebrovascular disease diabetes rheumatoid arthritis Alzheimers disease and some cancers and increases the risk of adverse pregnancies low birth weight preterm birth Periodontal inflammation is caused by the presence of gram-negative anaerobic bacteria called red complex in the subgingival plaque Red complex bacteria include Porphyromonas gingivalis Tannerella forsythia and Treponema denticola which are responsible for the onset and development of periodontal disease and are found predominantly in the deep periodontal pockets of patients with periodontitis
In addition genetic and environmental factors may increase an individuals susceptibility to periodontal disease The patients smoking and diabetes mellitus are risk factors for periodontitis Smoking is the most important environmental risk factor for periodontitis When subgingival biofilms of nonsmokersformer smokers were compared with smokers smokers exhibited a higher prevalence of red complex bacteria Additionally it has been reported that the potential negative effect of smoking on immune cells especially neutrophils makes the individual more susceptible to periodontitis It has been observed that periodontitis patients who smoke have more alveolar bone and attachment loss than non-smokers The main goal of periodontal treatment in patients diagnosed with periodontitis is based on removing subgingival biofilm and dental calculus Before applying surgical periodontal treatment which is the second step the first step is non-surgical periodontal treatment and is a prerequisite for deciding to proceed to the surgical stage In addition to non-surgical periodontal treatment Local andor systemic antibiotics anti-inflammatory drugs photodynamic therapy laser probiotics prebiotics and synbiotics statins ozone therapy epigenetic therapy and omega 3-6 can be used Probiotics modulate the oral microbiota by integrating beneficial bacteria into oral biofilms and preventing the treatment of oral microbial diseases Probiotics are defined as live microorganisms that provide health benefits when administered in sufficient amounts The most common probiotic bacteria are Lactobacillus and Bifidobacterium species Probiotic bifidobacteria have antimicrobial activity against periodontal pathogenic bacteria P gingivalis and Fusobacterium nucleatum In an in vitro study by Jasberg et al it was shown that species belonging to the genus Bifidobacterium could strongly adhere to the subgingival biofilm and significantly reduce the number of Porphyromonas gingivalis All bifidobacteria integrated well into subgingival biofilms consisting of Porphyromonas gingivalis Actinomyces naeslundii and Fusobacterium nucleatum but only significantly reduced the number of Pgingivalis in biofilms In the systematic review and meta-analysis evaluating the additional use of probiotics in patients with chronic periodontitis seven clinical studies evaluating the effectiveness of probiotics as an aid in scaling and root planing were included While four studies showed additional benefits of probiotics in reducing pocket depth and providing clinical attachment gain Three studies showed no significant differences In addition the difference between the average clinical attachment gain of the patients during the long-term follow-up phases was found to be significant Today studies show that probiotic toothpaste effectively prevents infectious diseases such as caries or periodontal disease However there are no studies on the effect of smoking on the effectiveness of toothpaste
Probiotic Toothpaste Content Glycerin Hydrated Silica Aqua Aloe Barbedensiz Leaf Juice Citric Acid Potassium Sorbate Sodium Benzoate Xanthan Gum BCoagulans BC4 Xylitol Sodium Coco-Sulfate Sodium Hydroxide Lavandula AngusTifolia Lavender Contains Oil Linalool
OHIP-14 survey The effect of the treatment on the patients quality of life is evaluated with a 14-question survey asked before and one month after non-surgical periodontal treatment
Periodontal indexes will be taken from all patients in the study group after taking systemic and dental anamnesis At the first examination session study samples will be taken clinical periodontal measurements plaque index gingival index bleeding index pocket depth attachment loss were used to evaluate the periodontal status in 6 regions of each tooth mesio-buccal buccal disto-buccal disto-palatal palatal mesio-palatal with the Williams periodontal probe Hu-Friedy USA will be measured and recorded and the oral health effective profile-14 OHIP-14 questionnaire will be recorded Afterward all teeth will be cleaned with an ultrasonic device and oral hygiene training will be given to the patients Patients will be taught how to brush their teeth using the modified Bass technique and how to use an interdental brush In the second session tooth brushing and interdental brush usage will be checked and if sufficient dental floss training will be given if inadequate brush usage will be explained again
In addition genetic and environmental factors may increase an individuals susceptibility to periodontal disease The patients smoking and diabetes mellitus are risk factors for periodontitis Smoking is the most important environmental risk factor for periodontitis When subgingival biofilms of nonsmokersformer smokers were compared with smokers smokers exhibited a higher prevalence of red complex bacteria Additionally it has been reported that the potential negative effect of smoking on immune cells especially neutrophils makes the individual more susceptible to periodontitis It has been observed that periodontitis patients who smoke have more alveolar bone and attachment loss than non-smokers The main goal of periodontal treatment in patients diagnosed with periodontitis is based on removing subgingival biofilm and dental calculus Before applying surgical periodontal treatment which is the second step the first step is non-surgical periodontal treatment and is a prerequisite for deciding to proceed to the surgical stage In addition to non-surgical periodontal treatment Local andor systemic antibiotics anti-inflammatory drugs photodynamic therapy laser probiotics prebiotics and synbiotics statins ozone therapy epigenetic therapy and omega 3-6 can be used Probiotics modulate the oral microbiota by integrating beneficial bacteria into oral biofilms and preventing the treatment of oral microbial diseases Probiotics are defined as live microorganisms that provide health benefits when administered in sufficient amounts The most common probiotic bacteria are Lactobacillus and Bifidobacterium species Probiotic bifidobacteria have antimicrobial activity against periodontal pathogenic bacteria P gingivalis and Fusobacterium nucleatum In an in vitro study by Jasberg et al it was shown that species belonging to the genus Bifidobacterium could strongly adhere to the subgingival biofilm and significantly reduce the number of Porphyromonas gingivalis All bifidobacteria integrated well into subgingival biofilms consisting of Porphyromonas gingivalis Actinomyces naeslundii and Fusobacterium nucleatum but only significantly reduced the number of Pgingivalis in biofilms In the systematic review and meta-analysis evaluating the additional use of probiotics in patients with chronic periodontitis seven clinical studies evaluating the effectiveness of probiotics as an aid in scaling and root planing were included While four studies showed additional benefits of probiotics in reducing pocket depth and providing clinical attachment gain Three studies showed no significant differences In addition the difference between the average clinical attachment gain of the patients during the long-term follow-up phases was found to be significant Today studies show that probiotic toothpaste effectively prevents infectious diseases such as caries or periodontal disease However there are no studies on the effect of smoking on the effectiveness of toothpaste
Probiotic Toothpaste Content Glycerin Hydrated Silica Aqua Aloe Barbedensiz Leaf Juice Citric Acid Potassium Sorbate Sodium Benzoate Xanthan Gum BCoagulans BC4 Xylitol Sodium Coco-Sulfate Sodium Hydroxide Lavandula AngusTifolia Lavender Contains Oil Linalool
OHIP-14 survey The effect of the treatment on the patients quality of life is evaluated with a 14-question survey asked before and one month after non-surgical periodontal treatment
Periodontal indexes will be taken from all patients in the study group after taking systemic and dental anamnesis At the first examination session study samples will be taken clinical periodontal measurements plaque index gingival index bleeding index pocket depth attachment loss were used to evaluate the periodontal status in 6 regions of each tooth mesio-buccal buccal disto-buccal disto-palatal palatal mesio-palatal with the Williams periodontal probe Hu-Friedy USA will be measured and recorded and the oral health effective profile-14 OHIP-14 questionnaire will be recorded Afterward all teeth will be cleaned with an ultrasonic device and oral hygiene training will be given to the patients Patients will be taught how to brush their teeth using the modified Bass technique and how to use an interdental brush In the second session tooth brushing and interdental brush usage will be checked and if sufficient dental floss training will be given if inadequate brush usage will be explained again
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None