Clinical trial

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

NCT05772039

Name

USM/JEPeM/20010069

Description

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

Trial arms

Trial start

2022-01-18

Estimated PCD

2023-07-15

Trial end

2023-08-15

Phase

Early phase I

Treatment

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.

Arms:

Topical application of 38% Silver Diammine Fluoride Solution at 12 months, Topical application of 38% Silver Diammine Fluoride Solution at 6 months, Topical application of 38% Silver Diammine Fluoride Solution at Baseline

Other names:

Riva Star, 38% Silver Diammine fluoride, SDF, Advanatge Arrest, Saforide

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.

Arms:

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months, Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months, Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline

Other names:

ClinPro White varnish, Sodium fluoride with functionalized tricalcium phosphate, NaF-fTCP

Size

Primary endpoint

Caries prevalence

Baseline

Frequency distribution of caries risk

Baseline

Mean score of oral health impact

Baseline

Patient behaviour towards dental treatment

Baseline

Mean score of pain experience

Baseline

Mean value of caries experience

Baseline

Extent of selected cavitated carious lesion using ICDAS

Baseline

Extent of selected cavitated carious lesion using FOTI

Baseline

Changes in the mean score of oral health impact

6 months

Changes in the mean score of patient behaviour towards dental treatment

6 months

Changes in the mean score of pain experience

6 months

Changes in the mean value of caries experience

6 months

Extent of selected cavitated carious lesion using ICDAS

6 months

Extent of selected cavitated carious lesion using FOTI

6 months

Changes in the mean score of oral health impact

12 months

Changes in the mean score of patient behaviour towards dental treatment

12 months

Changes in the mean score of pain experience

12 months

Changes in the mean value of caries experience

12 months

Extent of selected cavitated carious lesion using ICDAS

12 months

Extent of selected cavitated carious lesion using FOTI

12 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

Updated at

2023-03-16

1 organization

2 products

7 indications

Organization

Universiti Sains Malaysia

Product

Silver Diammine Fluoride

Indication

Early Childhood Caries

Indication