Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Remineralization of initial carious lesions
Study Overview
Brief Summary
This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.
Detailed Description
Dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure.
The treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). The application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion criteria of the participants:
- •Healthy patients with free medical history.
- •Age range 15-50 years.
- •Patients with high caries risk assessment according to Cariogram.
- •Patients with initial carious lesions at the facial surface of any teeth
- •High plaque index
- •Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study
Exclusion Criteria
- •of the participants:
- •Patients with a compromised medical history.
- •Patients with dentin caries
- •Extreme plaque accumulation and periodontal problems
- •Completely edentulous patients
- •Participants with a history of allergy to any of the drugs or chemicals used in the study.
- •Patients on any antibiotics during the past month
- •Inclusion criteria of the teeth:
- •The WSLs with LF measurements inside the range 14-20 were involved in this study.
- •The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study
- •Exclusion criteria of the teeth:
- •The white spot lesion scoring is (<14) or (>20) according to diagnodent
- •The white spot lesion scoring is other than 2, 3 according to ICDAS
- •White spot lesions due to hypomineralization or fluorosis
Arms & Interventions
preventive regimen using Herbal toothpaste(Himalaya)
The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals.
Intervention: Himalaya complete care toothpaste (Other)
preventive regimen using Fluoride based toothpaste(colgate)
preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals.
Intervention: colgate cavity protection (Other)
Outcomes
Primary Outcomes
Remineralization of initial carious lesions
Time Frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)
Secondary Outcomes
- Caries risk assessment(Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.)
Investigators
Yomna Hussin
Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Cairo University