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

NCT05772039 | Unknown Phase 4 DMC

• 1 other identifier: USM/JEPeM/20010069
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

SDF; NaF-fTCP; child behavior; pain experience; Wong-Baker Faces Pain rating scale; oral health-related quality of life; caries arrest; caries prevention; silver diammine fluoride; minimal intervention dentistry; Functionalized tricalcium phosphate; Sodium fluoride

Outcome Measures

Primary Outcomes (20)

• Caries prevalence

  Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition

  Baseline

• Frequency distribution of caries risk

  Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high

  Baseline

• 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

• Patient behaviour towards dental treatment

  Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive

  Baseline

• 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

• Mean value of caries experience

  Calculated by summation of number of decayed, missing and filled surfaces of dentition

  Baseline

• 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

• Extent of selected cavitated carious lesion using FOTI

  Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5

  Baseline

• 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

• 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

• 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

• Changes in the mean value of caries experience

  Calculated by summation of number of decayed, missing and filled surfaces of dentition

  6 months

• 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

• Extent of selected cavitated carious lesion using FOTI

  Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5

  6 months

• 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

• 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

• 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

• Changes in the mean value of caries experience

  Calculated by summation of number of decayed, missing and filled surfaces of dentition

  12 months

• 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

• Extent of selected cavitated carious lesion using FOTI

  Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5

  12 months

Secondary Outcomes (5)

• Number of participants reporting adverse events

  Baseline

• Percentage of dropouts

  6 months

• Number of participants reporting adverse events

  6 months

• Percentage of dropouts

  12 months

• Number of participants reporting adverse events

  12 months

Study Arms (6)

Topical application of 38% Silver Diammine Fluoride Solution at Baseline

ACTIVE COMPARATOR

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Drug: Topical application of 38% Silver Diammine Fluoride Solution

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

ACTIVE COMPARATOR

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Drug: Topical application of 38% Silver Diammine Fluoride Solution

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

ACTIVE COMPARATOR

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Drug: Topical application of 38% Silver Diammine Fluoride Solution

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline

EXPERIMENTAL

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

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

EXPERIMENTAL

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

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

EXPERIMENTAL

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

Interventions

Topical application of 38% Silver Diammine Fluoride Solution DRUG

* 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.

Also known as: Riva Star, 38% Silver Diammine fluoride, SDF, Advanatge Arrest, Saforide

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

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish DRUG

* 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.

Also known as: ClinPro White varnish, Sodium fluoride with functionalized tricalcium phosphate, NaF-fTCP

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

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• 3M ESPE: collaborator
• SDI Limited: collaborator

Study Sites (1)

Crescent Montessori School

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Dental Caries; Child Behavior

Interventions

silver diamine fluoride; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Anas Imran Arshad, MSc., BDS

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 16, 2023
• Study Start: January 18, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)