Design of a Multicomponent Intervention to Reduce the Risk of Exposure to High Concentrations of Fluoride in Children in Huila, Colombia
Phase: NA
Conditions: Fluorosis, Dental, Fluorosis
Sponsor: Universidad Antonio Nariño

Official Title: 
Design of a multicomponent intervention to reduce the risk of exposure to high 
concentrations of fluoride in children in Huila, Colombia  
 
 
NCT Number: 
Not yet assigned 
 
Document type: 
Study Protocol with Statistical Analysis Plan and Informed Consent Form 
 
 
Document Date: 
September 22, 2025 
 
 
Sponsor: 
Universidad Antonio Nariño (UAN) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The design of this trial protocol complies with the SPIRIT statement (Standard Protocol 
Items: Recommendations for Intervention Trials).  
A randomized controlled trial of parallel groups and two arms (intervention and non-
intervention groups) is proposed, with a 1:1 allocation ratio to determine the effectiveness 
of the multicomponent intervention in reducing the risk of exposure to high concentrations 
of fluoride in children (Fig. 1). 
 
Intervention and control conditions. 
 
Intervention. 
The program theory with changes and expected outcomes is presented in a logic model 
(Fig. 2). 
 
Implementation of the intervention. 
This intervention includes five components. Table 1 lists the components, thematic modules 
for implementation, and follow-up to the intervention. 
 
1. Installation of physical barriers: a reverse osmosis water filter will be installed in the 
intervention group's kindergarten, and staff will be trained in its operation, 
maintenance, and care to ensure its effectiveness. 
 
Educational sessions. 
Designed under the Dialoguing Interestructuring pedagogical model, which works on the 
three dimensions of the individual: cognitive, socio-affective, and practical.  
 
2. Educational sessions for parents: two weekly 45-minute meetings will be held over 
a period of six weeks to cover three thematic modules. The first aims to educate 
parents about the natural presence of fluoride in water and its relationship to adverse 
effects such as dental and skeletal fluorosis. The second consists of two sessions 
focused on identifying sources of fluoride intake such as food, salt, water, and dental 
products, and the adoption of safe practices in the home environment. The third 
module consists of two sessions that provide guidance on the use of fluoride in oral 
health, fluoridated toothpaste, adult supervision during brushing, oral hygiene habits, 
and regular dental visits (Table 2). 
 
 
 
 
 
 

Fig. 1. Study design outline to be applied in both municipalities. 
 
3. Educational sessions for children: consists of two sessions to be held over two 
weeks. It is designed with a playful-pedagogical approach, adapted to the cognitive 
level and development of early childhood. It includes question and answer games, a 
practical experiment on the right amount of toothpaste, an educational board game, 
role-playing about visits to the dentist, and supervised toothbrushing practice. Each 
educational session lasts 30 minutes and will be conducted simultaneously with 
module 3 for parents, in order to synchronize the content between parents and 
children and facilitate reinforcement of learning at home (Table 3) 
 
 
 
Kindergarten groups 
Intervention: 
Parent-child pairing 
Control: 
Parent-child pairing 
Baseline measurements 
First reinforcement 
Follow-up measurements 
Second reinforcement  
Follow-up measurements 
Final 
evaluations 
Start of study 
Study baseline 
1.
Physical barrier 
2.
Educational sessions 
3. Extension activities 
4. Maintenance phase 
Three months 
Six months 
Twelve months 
Randomization 

 
Fig. 2. Logical model of the intervention. 
 
 
4. Outreach activities: To ensure the sustainability of the intervention, kindergarten 
teachers will be trained. The goal is for them to integrate oral health content into their 
planning, replicating the lessons weekly with the children over a period of six months. 
The research team will conduct three reinforcement sessions three and six months 
after implementation. In addition, posters and brochures with key messages will be 
used to reinforce preventive practices in the school environment and maintain the 
visibility of the program (Table 1). 
 
5. Maintenance phase: (Table 1) The population will have free access to educational 
resources through the “Camaleón Sonriente cuida tus dientes” (Smiling Chameleon 
Takes Care of Your Teeth) platform, via the official link:  
https://sites.google.com/uan.edu.co/camalensonrientecuidatusdiente/p%C3%A1gin
a-principal?authuser=0 
 
Strategies for monitoring and maintaining adherence to the intervention. 
To ensure the reliability of the intervention in each of the components of the educational 
intervention, the entire team will be trained in advance for the implementation of the 
intervention, technical assistance will be provided to the team, and the intervention will be 
supervised by the intervention coordinator (Table 4).   
 
Control conditions. 
The control group intervention will include training on the cariogenic diet, flossing, and 
handwashing, provided to the parent-child pair. The training will be monitored, but the 
progress of the implementation will not be monitored. 
 
 

 
Table 1. Components, implementation, and monitoring of the multicomponent intervention to reduce 
the risk of fluoride exposure in children. 
Components of the 
multicomponent 
intervention. 
Thematic module of the 
multicomponent intervention 
to be implemented. 
Follow-up (baseline, 3, 6, and 
12 months) to the 
intervention. 
1. 
Physical 
barrier. 
Filter installation, use, care, and 
maintenance. 
Measurement of fluoride 
concentrations in water. 
 
2. 
Educational 
sessions for 
parents. 
Thematic module 1. “The 
guardian of fluoride footprints.”  
Thematic module 2. “The key to 
a risk-free smile.” 
Thematic module 3. “The path to 
a stain-free smile.” 
 
Evidence of the activities 
carried out in each session will 
be collected. 
Survey application. 
 
3. 
Educational 
sessions for 
children. 
Thematic module 3. The path to 
a stain-free smile. 
Educational session 4: 
directions of the fluoride mission 
and session 5: walking safe 
paths. 
 
Measurement of fluoride 
concentrations in urine.  
4. 
Outreach 
activities. 
Three reinforcement sessions 
will be held at three and six 
months. 
Advertisements. 
A weekly activity with the 
teacher in the classroom.  
 
Survey application. 
Activity checklist. 
Technical assistance. 
5. 
Maintenance 
phase. 
Engaging participants in the 
“Smiling Chameleon Takes Care 
of Your Teeth” educational 
model 
Final survey. 
Activity checklis. 
  
Expected results.  
The multicomponent intervention is expected to be more effective than the conventional 
strategy in reducing fluoride exposure in children.  
 
Primary outcomes.  
Decrease in urinary fluoride concentrations in children in the intervention group. 
 
Secondary outcomes.  
Positive changes in knowledge, attitudes, and practices (KAP) to reduce the risk of fluoride 
exposure in children. 
Reduction in fluoride concentrations in water. 
 
 
 

Table 2. Educational sessions for parents in the multicomponent intervention to reduce the 
risk of fluoride exposure in children and learning objectives. 
Sessions  
Learning objectives 
Thematic module 1. “The guardian of fluoride footprints.”  
Session 1: The journey of 
fluoride in water. 
- Explore water as the primary natural source of fluoride exposure. 
- Learn about the presence of fluoride in the environment. 
- Learn about dental fluorosis and skeletal fluorosis as effects of 
chronic fluoride exposure. 
Thematic module 2. “The key to a risk-free smile.” 
Session 2: The mystery of 
fluoride. 
- Learn about the sources of risks associated with fluoride 
exposure. 
- Define the presence of fluoride in salt. 
- Identify the presence of fluoride in frequently consumed foods. 
- Recognize the presence of fluoride in dental products. 
 
Session 3: The secret of 
fluoride flavors. 
- Identify fluoride intake from water. 
- List fluoride intake from table salt. 
- Indicate fluoride intake from food. 
- Learn about fluoride intake from dental products. 
- Label fluoride content in salt, food, and dental products. 
Thematic module 3. “The path to a stain-free smile.” 
Session 4: Directions for the 
fluoride mission. 
- Organize the importance and role of fluoride in oral health. 
- Review the proper use of fluoride in oral health. 
 
Session 5: Walking safe 
paths. 
- Distinguishing between appropriate doses of fluoride in oral health  
care. 
- Recognizing healthy oral hygiene habits for controlling fluoride 
intake. 
- Recognizing the importance of adult supervision in the oral 
hygiene process. 
- Recognizing the importance of regular visits to the dentist. 
 
 
Participants and schedule 
Sample size. 
The sample size (parent-child pair) will be estimated based on one of the outcome variables: 
urinary fluoride concentration. This will use the formula for the difference in means as 
follows:  n = 4f(α, β) (
s2
d2) therefore: 
f(α, β): α, β (Type I error) 0,05 y f (Power) 0,90. According to the table of critical values for 
the confidence level and power, this corresponds to 8,56. 
s2: Variability in urinary fluoride concentrations is 2,42 mg/L, taken from a measurement of 
urinary fluoride concentrations in children from El Juncal previously. 
d2: Clinically significant difference, urinary fluoride concentrations 1.5 mg/L taken from a 
measurement of urinary fluoride concentrations in children from El Juncal. 
n = 4f(α, β) (s2
d2) 
n = 4(8,56) (2,422
1,52 ) 

n = 34,24x5,8564
2,25
 
n = 34,24x5,8564
2,25
 
n = 200,523136
2,25
 
n = 89,1213 ≅90 
 
The calculated sample size corresponds to 90 pairs, 45 for the intervention group and 45 for 
the control group. 
For the community outreach component, all teachers and staff working in the kindergartens 
attended by eligible children will be invited to implement the training component. Those who 
voluntarily agree to participate in the study will be eligible. 
 
Table 3. Sessions for children in the multicomponent intervention to reduce the risk of 
fluoride exposure in children and learning objectives. 
Sessions  
Learning objectives 
Thematic module 3. “The path to a stain-free smile.” 
Session 4: Directions for the 
Fluoride Mission 
- Understand what fluorides are and why they are important for 
oral health. 
- Learn some important precautions when using dental products 
with fluoride. 
 
Session 5: Walking safe paths. 
- Distinguishing between appropriate doses of fluoride in oral 
health care. 
- Recognizing healthy oral hygiene habits for controlling fluoride 
intake. 
- Recognizing the importance of regular visits to the dentist. 
 
 
Recruitment of kindergartens and parent-child pairs.  
The unit of analysis will be the kindergartens. The participant recruitment process will begin 
with the sending of a letter requesting voluntary participation in the study. Subsequently, a 
meeting will be held with the administrators and teachers of the selected kindergartens to 
present the objectives and procedures of the study. For the recruitment of the parent-child 
dyad, parents will be invited to participate through the institution's official communication 
channels. The intervention will be presented in detail to the parents/caregivers, and they will 
be asked to sign the informed consent form for both parents and children, thus ensuring a 
structured and transparent process.  
 
Schedule: Parents and children will be assessed at four points during the study: baseline 
(T0, start of the study, before implementing the intervention), three months (T1), six months 
(T2), and twelve months (T3) at the end of the maintenance phase (Table 5). 
 
 
 

Table 4. Monitoring the fidelity of implementation of the multicomponent intervention to 
reduce the risk of fluoride exposure in children. 
Intervention 
actions. 
Intervention 
components that 
should be 
implemented. 
Inadequate 
reliability is 
triggered. 
Follow-up and 
actions to address 
it. 
Physical barrier. 
Installation of filters in 
kindergartens prior to 
implementation of the 
intervention. 
Understanding how 
to use the filter. 
Use of less than 
70% of the filter. 
 
Follow-up visits and 
checklists. 
Educational sessions 
for parents. 
The five educational 
sessions are held 
twice a week. 
Parents participate in 
80% of the sessions 
and activities. 
Fewer than five 
sessions held. 
Team staff will report 
if there is a low level 
of understanding of 
the materials used in 
the session. 
Team staff will report 
if participant 
attendance is less 
than 70%. 
 
Weekly meetings 
with the team to 
verify information 
about the 
educational 
sessions held during 
the week. 
 
Direct observation 
by the work team. 
 
Checklists for 
participation in 
educational 
sessions. 
 
Technical 
assistance. 
Educational sessions 
for children. 
The two educational 
sessions are held 
over the course of a 
week. 
Children participate in 
80% of the sessions 
and activities. 
Team staff will report 
if there is a low level 
of understanding of 
the materials used in 
the session. 
Team staff will report 
if participant 
attendance is less 
than 70%. 
 
Outreach activities. 
Reinforcement 
sessions:  
Three months:  
Three educational 
sessions. One per 
week. 
Six months: 
Three educational 
sessions. One per 
week. 
 
Monthly follow-up 
visits: advertisements, 
two advertisements 
Fewer than 3 
sessions taught. 
Team staff will report 
if there is a low level 
of understanding of 
the materials used in 
the session. 
Team staff will report 
less than 70% 
attendance by 
participants. 
One out of every two 
advertisements was 
not completed within 
Monthly meetings 
with the team to 
verify information 
about the 
educational 
sessions applied in 
the reinforcements. 
 
Checklist for 
participation in 
educational 
sessions. 
 
Direct observation. 
 

are derived from each 
session. 
Material sent home 
for reference and 
practice.  
 
Activities in natural 
science class. Two 
classroom activities 
derived from each 
session. 
 
the established time 
frame. 
One out of every two 
classroom activities 
was not completed.  
Activity checklist. 
 
Technical 
assistance. 
Maintenance phase 
Visits to educational 
model activities. 
Less than 70% of 
the population 
visiting educational 
model activities. 
Direct observation. 
 
Technical 
assistance. 
 
 
Method for assigning the intervention. 
Randomization and blinding 
Participants will be randomly assigned to the intervention in the kindergartens. To do this, 
the list of parent-child pairs from each kindergarten who have agreed to participate in the 
study will be used. Randomization will be performed using SPSS V.25 software, using the 
transformation module to generate a table of random numbers according to the calculated 
sample size. 
Data collection personnel will remain blinded and will not know which group (intervention or 
control) participants belong to. Similarly, parent-child pairs will not know which research 
group they belong to. 
 
Method for data collection. 
Fluoride concentration in water. 
To calculate fluoride concentrations in water, liquid will be collected from underground wells 
in the municipalities of El Juncal and Riofrío in 250 ml polyethylene bottles. They will be pre-
treated with 10% HNO3 for 2 hours, rinsed with distilled and deionized water, and dried (to 
avoid contamination). The containers will also be rinsed three times with the same sampling 
water before sample collection. After sample collection, the containers will be refrigerated at 
three degrees Celsius and will be transferred and stored in the laboratory of Antonio Nariño 
University until analysis. 
 
 

Table 5. Schedule of study measures and deadlines for implementing the multicomponent intervention to reduce the risk of fluoride 
exposure in children.  
Procedure - 
Activity 
Registration of 
participants 
T0 – Baseline 
(before 
implementation of 
the intervention) 
Implementation 
of the 
intervention 
(first three 
months) 
T1 - Follow-up 
measurement 
Implementation of 
the intervention 
(six months) 
T2 — Follow-up 
measurement 
(six months) 
Implementation of the 
intervention 
(maintenance phase) 
T3 - Final 
measurement 
(after one year) 
Kindergarten 
assignment 
X 
Signed consent 
form 
X 
Verify participant 
eligibility criteria 
X 
Implementation of 
the intervention 
X 
X 
X 
Fluoride 
concentrations in 
water 
 
X 
 
X 
X 
X 
Fluoride 
concentrations in 
urine 
X 
X 
X 
X 
CAP survey for 
parents 
X 
X 
X 
X 
Monitor fidelity of 
intention 
X 
X 
X 
X 
 
 
 

 
Fluoride concentration in urine. 
To estimate fluoride levels in the urine of participating children, parents will be trained to 
collect samples. The first urine of the morning will be collected, transferred to sterile 50 ml 
Falcon tubes, and a standard volume of 20 ml will be taken for analysis. After sample 
collection, the containers will be refrigerated (three degrees Celsius), transported, and 
stored in the laboratory until analysis. This sampling will be carried out at four points in time: 
before the intervention is implemented and after it at three, six, and twelve months.  
 
Quantification of fluoride in water and urine. 
The quantification of fluoride ions in groundwater and urine samples will be performed using 
a potentiometer equipped with a fluoride ion-selective electrode, specifically model HI 5315. 
Samples will be analyzed in duplicate, after adding TISAB II buffer with CDTA to stabilize 
the pH and compensate for interference from other ions. To ensure the accuracy and validity 
of the results, certified reference materials, such as the NIST-USA 1984 standard (SRM 
3183), will be used. In the case of urine samples, fluoride concentrations will be adjusted by 
dilution to control for variations in fluid balance, specifically through the determination of 
urinary creatinine. The latter will be quantified using a Genesys 10S UV-VIS 
spectrophotometer (Thermo Scientific, USA). Finally, urinary fluoride levels will be 
expressed in milligrams of fluoride per gram of creatinine, allowing for a more representative 
and standardized analysis of fluoride exposure in the individuals studied. 
 
Knowledge, Attitudes, and Practices Survey.   
To assess changes in parents' knowledge and attitudes, the Knowledge, Attitudes, and 
Practices (KAP) survey will be administered, after validation. The instrument was designed 
for this purpose, taking into account the components of the intervention. The knowledge 
section consists of 12 items and explores parents' understanding of natural and non-natural 
sources of fluoride and its effects on oral and systemic health. The attitudes section consists 
of 10 items and identifies perceptions, beliefs, motivations, and willingness to act in 
response to fluoride risk, water quality, willingness to change habits, and dental follow-ups. 
The practices section, with 9 items, addresses information on current behaviors related to 
consulting fluoride content, modifying water sources, dental care, and supervision in the use 
of dental products. Each section of the instrument includes ordinal scale variables and 
provides an overall score that allows each section to be classified as good, fair, or poor. 
 
Participant retention. 
To facilitate retention with high levels of parent-child participation, this intervention aims to 
promote the bond between parents and children and the research team. Initially, awareness 
will be raised by emphasizing the general health risks to the community and specifically to 
children. In addition, it will be fun for children, attractive to parents/caregivers, and culturally 
sensitive. 
 
 
 

 
Data analysis.  
The analysis seeks to compare changes between the intervention and control groups over 
time. The information will be recorded in a digital database designed in Microsoft Excel 
(2021), each dyad will be coded, the data will be stored securely with limited access, and 
data quality assurance will be ensured through data validation. 
To this end, an analysis will be performed for each component of the intervention to 
determine the effectiveness of each one. First, comparisons will be made between the 
intervention group and the control group at the beginning of the study using the Chi-square 
(χ²) test for categorical variables. For continuous variables, such as age and baseline urinary 
fluoride concentrations, Student's t-test will be used if they have a normal distribution or the 
Mann-Whitney U test if the distribution is non-parametric. 
For longitudinal measurements, Generalized Estimating Equations (GEE) models will be 
used to compare the means of fluoride concentrations in water and urine between the two 
groups over time (baseline measurements, at 3, 6, and 12 months). For this analysis, these 
parameters will be used to model the relationship between fluoride concentrations and the 
model variables, and an autoregressive correlation will be implemented to model the 
relationship between repeated measurements in each individual. 
The main analysis will focus on the difference-in-differences (DID) method to estimate the 
net effect of the intervention. Under the assumption of parallel trends, this method will allow 
us to compare changes in the intervention group with those in the control group over time. 
A linear regression model will be used to implement the DID, where the interaction coefficient 
between the group (intervention vs. control) and time (before vs. after) will represent the 
actual effect of the intervention. If the distributions are not normal, variable transformations 
or the use of generalized linear models will be considered. 
Data on parents' knowledge, attitudes, and practices will be analyzed as ordinal variables. 
Comparisons within each group before and after the intervention will be evaluated using the 
Wilcoxon test for paired data or the Student's t-test for paired samples, as appropriate. For 
comparisons between groups (intervention vs. control), the Mann-Whitney U test or 
Student's t-test for independent samples will be used. 
A significance level of p < 0.05 will be established to determine whether the differences are 
statistically significant. 
 
Analysis to handle missing data: Data from parent-child dyads who drop out of the 
intervention before completion will be managed separately. A Student's t-test analysis will 
be performed to compare the baseline mean urinary fluoride concentrations of children who 
dropped out of the study during the one-year follow-up period with those who remained in 
the study. If they dropped out of the study after T1 or T2, the parents' CAPs will also be 
compared with those who remained. 
 
 
 
 
 

 
INFORMED CONSENT TO PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
PRINCIPAL INVESTIGATOR: Claudia Lorena García Rojas. 
WHERE THE STUDY IS BEING CONDUCTED: Department of Huila.. 
 
You are being invited to participate in this research study. 
Before deciding whether or not to participate, you should read 
and understand each of the following sections. This process is 
known as informed consent. Please feel free to ask any 
questions you may have to clarify any doubts you may have.  
 
Once you have understood the study and if you wish to 
participate, you will be asked to sign this consent form, a 
signed and dated copy of which will be given to you. 
 
General Objective 
- To evaluate the effectiveness of a multicomponent 
intervention to reduce the risk of fluoride exposure in 
children in the department of Huila. 
 
1. Justification for the study. 
This study seeks to evaluate the effectiveness of a 
multicomponent intervention to reduce the risk of exposure to 
high concentrations of fluoride in children in the department 
of Huila, in accordance with the guidelines and actions for 
prevention and control of risks associated with the event. By 
coordinating the different actors and knowing that educational 
interventions modify habits in the population, we propose to 
evaluate the effectiveness of this intervention in the 
population.  

 
 
2. Benefits of the study.  
As a university with a dentistry faculty in the region, we 
embrace our social responsibility as a management policy in 
line with the challenges of the world in this century, whose 
fundamental objective is to develop a series of actions that 
strengthen the university's relationship with society. Hence 
the motivation of the oral health research group at the Antonio 
Nariño University School of Dentistry to reach out to the 
population that needs it. This is done after analyzing the 
needs of the population and the capacity to intervene, 
evaluating and developing strategies that result in the well-
being of society. The goal is to demonstrate behavioral change 
for the better well-being of the children in the department.  
Likewise, another benefit would be related to preventive 
actions, mainly aimed at reducing the intake of water with high 
concentrations of fluoride, including during pregnancy and 
throughout childhood, especially up to the age of eight. The 
same applies to the consumption of water, whether natural or 
artificial, which is generally fluoridated, as well as food 
preparation, the use of fluoridated toothpaste in children, 
and preferably a diet high in calcium, magnesium, and 
antioxidants. 
 
3. Study procedures.  
An initial phase will be carried out to measure fluoride 
concentrations in water and urine, diagnose dental fluorosis, 
and complete a survey. Subsequently, the multi-component 
intervention will be implemented, followed by a post-
implementation evaluation of both the intervention group and 
the control group. 

 
4. Risks associated with the study (according to Resolution 
8430 of 1993):  
This study will be conducted to evaluate the effectiveness of 
a multicomponent intervention for children exposed to fluoride. 
The risk of the research is minimal, as the effects of natural 
fluoride exposure on children will be determined through the 
implementation of the TF Index for diagnosis and to determine 
the level of fluoride exposure. 
 
5. Clarifications:   
Your decision to participate in the study is completely 
voluntary. 
There will be no adverse consequences for you if you do not 
accept the invitation. 
If you decide to participate in the study, you may withdraw at 
any time, even if the researcher in charge does not ask you to 
do so, and you may or may not give reasons for your decision, 
which will be respected in its entirety.  
You will not incur any expenses during the study.  
You will not receive payment for your participation.  
During the course of the study, you may request updated 
information about it from the principal investigator. 
The information obtained in this study, used to identify each 
patient, will be kept strictly confidential by the research 
team. 
 
If you have any questions or require clarification, please 
contact Claudia Lorena García Rojas at 3166917683. 
 

If you believe that there are no doubts or questions regarding 
your participation, you may, if you wish, sign the informed 
consent form that is part of this document. 
 
 
INFORMED CONSENT. 
I, __________________________________ ID c.c Nº ____________ 
of ________ have read and understood the above information, 
and my questions have been answered satisfactorily by the 
researcher who interviewed me. I have been informed and 
understand that the data obtained in the study may be published 
or disseminated for scientific purposes. Therefore, I wish to 
voluntarily participate in the research project. 
 
__________________________________________ 
Participant's First and Last Name 
 
_________________________ 
Participant's Signature. 
C.C Nº  
 
_________________________ 
Witness' Name 
 
__________________________ 
Witness' Signature. 
C.C Nº 
 
This section must be completed by the researcher (or their 
supervisor). 
I have explained to Mr./Msal ________________________ the 
purpose of the research and the risks and benefits of their 

participation. I have answered the questions to the best of my 
knowledge and asked if they have any questions. I acknowledge 
that I have read and understand the applicable regulations for 
conducting research with human subjects and that I abide by 
them (Resolution 8430 of 1993). Once the question-and-answer 
session was concluded, this document was signed.. 
 
_____________________________  
 
__________________ 
Researcher's Signature.   
 
 
Date 
 
 
_____________________________________________________________
_____ 
 
INFORMED WITHDRAWAL 
I 
___________________________________________________ 
identified 
with 
the 
CC 
_________________________ 
of 
_________________ voluntarily participated in the study until 
the ____ day of the month ______ of the year ____, exercising 
the right that was mentioned to me from the beginning of the 
research, which states that I can withdraw at any time, stating 
the following reasons: 
 
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________

_____________________________________________________________
___________________________________ 
 
The following sign on the record:: 
 
_____________________________________________________________
___ 
Name and Signature of the person participating in the project 
or legal guardian who withdraws from participating in the study 
C.C. No. 
 
__________________________________________ 
Signature of Witness (1) 
C.C. No.  
 
__________________________________________ 
Signature of Witness (2) 
C.C. No. 
 
___________________________________________ 
Signature of Principal Investigator  
C.C. No.