Study: NCT03529500

Intervention type: DIAGNOSTIC_TEST
Intervention: Caries detection - dmtf index
Description: Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).~The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index.

Intervention type: DIAGNOSTIC_TEST
Intervention: Caries detection - dmtf index
Description: Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).~The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index.

Intervention type: DIAGNOSTIC_TEST
Intervention: Caries detection - dmtf index
Description: Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).~The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index.

Intervention type: DIAGNOSTIC_TEST
Intervention: Caries detection - dmtf index
Description: Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).~The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva flow rate
Description: Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: \< 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and \> 2.0 ml/min = high flow.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva flow rate
Description: Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: \< 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and \> 2.0 ml/min = high flow.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva flow rate
Description: Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: \< 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and \> 2.0 ml/min = high flow.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva flow rate
Description: Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: \< 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and \> 2.0 ml/min = high flow.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva Buffering Capacity
Description: an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva Buffering Capacity
Description: an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva Buffering Capacity
Description: an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.

Intervention type: DIAGNOSTIC_TEST
Intervention: Saliva Buffering Capacity
Description: an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.