Clinical trial NCT04446390: Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: * Inclusion criteria of the participants:

  1. Healthy patients with free medical history.
  2. Age range 15-50 years.
  3. Patients with high caries risk assessment according to Cariogram.
  4. Patients with initial carious lesions at the facial surface of any teeth
  5. High plaque index
  6. 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:

  1. Patients with a compromised medical history.
  2. Patients with dentin caries
  3. Extreme plaque accumulation and periodontal problems
  4. Completely edentulous patients
  5. Participants with a history of allergy to any of the drugs or chemicals used in the study.
  6. Patients on any antibiotics during the past month
* Inclusion criteria of the teeth:

  1. The WSLs with LF measurements inside the range 14-20 were involved in this study.
  2. The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study
* Exclusion criteria of the teeth:

  1. The white spot lesion scoring is (\<14) or (\>20) according to diagnodent
  2. The white spot lesion scoring is other than 2, 3 according to ICDAS
  3. White spot lesions due to hypomineralization or fluorosis

Primary outcomes:
measure: Remineralization of initial carious lesions
timeFrame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Secondary outcomes:
measure: Caries risk assessment
timeFrame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University, Faculty of Oral and Dental Medicine
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: