Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life

Quality of Life Clinical Trial

Official title:

Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05772039
• Other study ID #: USM/JEPeM/20010069
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 18, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: March 2023
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is still a need for the assessment of different minimal intervention strategies and treatments focusing on the prevention and arrest of carious lesions of primary molars The evidence-based clinical practice guideline on non-restorative treatments for cavitated carious lesions advocate the use of silver diammine fluoride biannually for high caries risk patients

Description:

Although SDF has been proven to be highly effective in carious lesion arrest and prevention, the staining effect, metallic taste due to silver content and the minimal mucosal irritation have been noted as primary cause of disinterest among clinicians in the use of this material. The use of NaF-fTCP as a caries preventive material has not been studied widely. The importance of oral hygiene education and diet modification to achieve an effective caries control has been widely discussed. The off-label use of NaF-fTCP as a caries arresting agent has not been studied on primary dentition. There is a dearth of evidence regarding the effectiveness of NaF-fTCP towards caries arrest and prevention in pragmatic settings. A comparison between the SDF and NaF-fTCP application on the cavitated carious primary molars and their effect on the oral health-related quality of life of the children has not been published in the literature.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion criteria:

Children will be invited to participate in the trial if they fulfil the entire selection

criteria as described below:

• 4 to 6 years-of-age
• Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs
• Up to three teeth per each participant will be selected for intervention
• Has normal salivary flow rate
• Does not consume medications regularly for any medical condition
• Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months Exclusion criteria:

Children will be excluded from the trial if they fulfil any of the following criteria:

• Presence of any pain, ulceration, fistula/sinus or an abscess
• Premature hypermobility of carious teeth which can be potentially included in the study
• History of allergy to any product containing silver compounds
• Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

Related Conditions & MeSH terms

• Behavior, Child
• Dental Caries
• Dental Caries Extending Into Dentin
• Dental Caries in Children
• Early Childhood Caries
• Quality of Life

Intervention

Drug:
• Topical application of 38% Silver Diammine Fluoride Solution
Application of petroleum jelly on lips and around the mouth for prevention of temporary silver tattoo. Before SDF application, the affected area will be thoroughly dried and isolated using the cotton rolls or dri-angle. Isolation throughout the procedure and following three minutes is considered most desirable. The varnish should be allowed to be in place for 60 seconds. This is the most critical step in the process. Applied varnish will be dried with gentle flow of compressed air. SDF will be applied with a microbrush to all carious lesions and to all pits and fissures on posterior (molar) teeth for 60 seconds. To avoid gingival or mucosal irritation, contact of varnish with any oral tissue other than affected area will be avoided. If the application time is shorter due to unforeseen reasons reapplication will be considered.
• Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
According to manufacturer, Clinpro® White Varnish can be applied to tooth surfaces where plaque is present. A prophylaxis is not required. The applicator brush provided along is used to thoroughly mix the varnish inside the single-unit dose pack, since components of all sodium fluoride varnishes are separate during storage. Excessive contact with soft tissue should be avoided. Only enough varnish to form a thin coating on the desired treatment area should be used. After application, patient should be instructed to close their mouth to set the varnish. Rinsing or suctioning immediately after application is not recommended. The operator might appreciate the formation of a thin coating on the teeth and the patient should be informed that they may feel a thin coating when rubbing the treated area with their tongue.

Locations

Country	Name	City	State
Pakistan	Crescent Montessori School	Lahore	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	3M ESPE, SDI Limited

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries prevalence	Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition	Baseline
Primary	Frequency distribution of caries risk	Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high	Baseline
Primary	Mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	Baseline
Primary	Patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	Baseline
Primary	Mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	Baseline
Primary	Mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	Baseline
Primary	Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	Baseline
Primary	Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	Baseline
Primary	Changes in the mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	6 months
Primary	Changes in the mean score of patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	6 months
Primary	Changes in the mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	6 months
Primary	Changes in the mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	6 months
Primary	Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	6 months
Primary	Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	6 months
Primary	Changes in the mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	12 months
Primary	Changes in the mean score of patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	12 months
Primary	Changes in the mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	12 months
Primary	Changes in the mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	12 months
Primary	Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	12 months
Primary	Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	12 months
Secondary	Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	Baseline
Secondary	Percentage of dropouts	Frequency of participants which either withdraw and do not consent for follow up	6 months
Secondary	Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	6 months
Secondary	Percentage of dropouts	Frequency of participants which either withdraw and do not consent for follow up	12 months
Secondary	Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	12 months