Dental remineralization: effects of fluoride and calcium phosphate-based varnishes on the saliva and plaque index of children at high risk of tooth decay

Effects of fluoride and calcium phosphate-based varnishes on plaque index and salivary pH, lactic acid, trace elements and bacterial count of children at high risk

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13681286

Enrollment

Registered

2020-05-26

Start date

2017-06-01

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Oral Health Dental caries

Interventions

Participants were randomized to control (placebo), MI Varnish (CPP-ACP with sodium fluoride 5%) or Clinpro White Varnish (fTCP with sodium fluoride 5%) applied every 3 months. Baseline and three-month

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged 4-12 years attending the Integrated Child Dentistry Clinic of the University of Murcia for checkups or dental treatment who presented a high or extreme risk of caries according to the CAMBRA protocol

Exclusion criteria

Exclusion criteria: 1. Children who had received fluoride varnish or other permanent surface treatment containing fluoride in the previous 6 months 2. Children fitted with orthodontic apparatus 3. Children living in an area with fluoridated drinking water 4. Children with moderate or severe fluorosis or other morphological or anatomical abnormalities of dental development 5. Children with systemic diseases causing physical limitations 6. Children with allergy or proven/suspected sensitivity to milk proteins

Design outcomes

Primary

Measure	Time frame
Measured at baseline, 3, 6, 9 and 12 months: 1. pH measured using a pH test strip (range 4.0–9.0; Code. 1.16996.0001; Reflectoquant™ Merck, Darmstadt, Germany) introduced in an RQflex®10 reflectometer (Merck Millipore, Darmstadt, Germany) 2. Lactic acid concentration measured using a lactic acid test strip (range 1.0-60.0 mg/L; Code. 1.16127.0001; Reflectoquant™ Merck, Darmstadt, Germany) introduced in an RQflex® 10 reflectometer (Merck Millipore, Darmstadt, Germany) 3. Trace elements in saliva (24Mg, 31P, 66Zn, 23Na, 27Al, 39K, 44Ca, 52Cr, 55Mn, 57Fe, 59Co, 63Cu, 75As, 111Cd, 137Ba and 208Pb) measured using mass spectrometry with inductively coupled argon plasma (ICP-MS Agilent 7900; Agilent Technologies Inc.; CA; USA) 4. Plaque index measured using a three-tone discoloring agent (Triplaque, GC, Leuven, Belgium) and Turesky modification of the Quigley-Hein plaque index scale. Additionally, the researchers developed their own Plaque Maturity and Acidity Index (PMAI) 5. Quantitative analysis of bacterial load in saliva samples by qPCR using universal primers on the 16S ribosomal gene with high coverage rate in all bacteria PCR (Polymerase Chain Reaction). DNA extraction performed with the Maxwell AS1290 LEV Blood DNA Kit (Promega Biotech Ibérica S.L, Madrid, Spain). DNA read by fluorimetry on the Prusga Quantus kit with the Quantifluor ONE dsDNA System (Promega Biotech Ibérica S.L, Madrid, Spain) Measured at baseline and 12 months: 1. 19F measured in saliva using an ion-specific fluoride electrode (Orion 9609 BNWP, Thermo Fisher Scientific Inc. Waltham, USA) coupled to an ion analyzer (Orion EA-940 Thermo Fisher Scientific Inc. Waltham, USA) 2. Caries index using the dmfs/DMFS (decayed, missing and filled teeth surface)	—

Measure

Time frame

Measured at baseline, 3, 6, 9 and 12 months: 1. pH measured using a pH test strip (range 4.0–9.0; Code. 1.16996.0001; Reflectoquant™ Merck, Darmstadt, Germany) introduced in an RQflex®10 reflectometer (Merck Millipore, Darmstadt, Germany) 2. Lactic acid concentration measured using a lactic acid test strip (range 1.0-60.0 mg/L; Code. 1.16127.0001; Reflectoquant™ Merck, Darmstadt, Germany) introduced in an RQflex® 10 reflectometer (Merck Millipore, Darmstadt, Germany) 3. Trace elements in saliva (24Mg, 31P, 66Zn, 23Na, 27Al, 39K, 44Ca, 52Cr, 55Mn, 57Fe, 59Co, 63Cu, 75As, 111Cd, 137Ba and 208Pb) measured using mass spectrometry with inductively coupled argon plasma (ICP-MS Agilent 7900; Agilent Technologies Inc.; CA; USA) 4. Plaque index measured using a three-tone discoloring agent (Triplaque, GC, Leuven, Belgium) and Turesky modification of the Quigley-Hein plaque index scale. Additionally, the researchers developed their own Plaque Maturity and Acidity Index (PMAI) 5. Quantitative analysis of bacterial load in saliva samples by qPCR using universal primers on the 16S ribosomal gene with high coverage rate in all bacteria PCR (Polymerase Chain Reaction). DNA extraction performed with the Maxwell AS1290 LEV Blood DNA Kit (Promega Biotech Ibérica S.L, Madrid, Spain). DNA read by fluorimetry on the Prusga Quantus kit with the Quantifluor ONE dsDNA System (Promega Biotech Ibérica S.L, Madrid, Spain) Measured at baseline and 12 months: 1. 19F measured in saliva using an ion-specific fluoride electrode (Orion 9609 BNWP, Thermo Fisher Scientific Inc. Waltham, USA) coupled to an ion analyzer (Orion EA-940 Thermo Fisher Scientific Inc. Waltham, USA) 2. Caries index using the dmfs/DMFS (decayed, missing and filled teeth surface)

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026