Cerebral PalsyNCT02322983
Conscious Sedation With Nitrous Oxide in Control of Stress During Dental Care for Individuals With Cerebral Palsy
A study of Cerebral Palsy, run by Universidade Cruzeiro do Sul at 1 site in Brazil.
Trial summary
Cerebral Palsy induces oral alterations that impact on oral health, requiring dental treatment. The objective of this study was to evaluate the use of conscious sedation with nitrous oxide (N2O) in the control of stress during dental treatment in individuals with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Cerebral Palsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cerebral Palsy medical diagnosis;
- Age over 3 years old without distinction by gender;
- Patients with any clinical patterns of Cerebral Palsy;
- Patients with caries in at least two molars (primary or permanent), indicating anesthetic use for performing the restorative procedure.
Who cannot join
- Patients with chronic respiratory problems (such as chronic bronchitis, COPD) or acute (like flu with nasal congestion and active pneumonia) as these conditions contraindicate the use of N2O;
- Cerebral Palsy patients with genetic syndromes associated;
- Patients whose caregivers refused to sign the Instrument of Consent and the Consent of the Use of Conscious Sedation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.
Cerebral Palsy induces oral alterations that impact on oral health, requiring dental treatment. The objective of this study was to evaluate the use of conscious sedation with nitrous oxide (N2O) in the control of stress during dental treatment in individuals with Cerebral Palsy.
Read the detailed description
Were invited and accepted to participate in this study, 77 individuals with Cerebral Palsy who attended the outpatient clinic of San Francisco Home School (SFHS) at the time of data collection.
This study served as a non-randomized experimental trial conducted between 2011/2012 at dental ambulatory in the SFHS. Dental care routines have been established, by standardizing procedures and ensuring the reproducibility of the method of sedation. In the initial consultation, medical history taking (collecting sociodemographic data of the participants) and dental examination was performed. Data relating to the Cerebral Palsy clinical standard were collected from medical records of patients and noted in the evaluation sheet developed specifically for this research. Were provided to guardians the clarifications regarding sedation technique and treatment planning.
At dental examination the diagnostic criteria of caries followed those proposed by the World Health Organization (WHO). On the second visit, the patient was stabilized in the dental chair under mechanical contention. Performed adaptation and selection of nasal mask, monitoring equipment were positioned, starting the observation and recording of the behavioral and physiological records in the evaluation sheets. The proportion of gas was manipulated relative to the percentage between nitrous oxide and oxygen to achieve optimal sedation. In this study, it was considered a good sedation for Cerebral Palsy patient when he showed a certain degree of relaxation, which becomes more cooperative with treatment.
Behavioral assessment in relation to dental treatment was measured by Venham's Score, standard used for behavioral assessment of the dental patient, and the measurement performed according to the patient's behavior during the dental procedure.
Due to the subjectivity which compose the diagnosis of diseases or behavior analysis, it is common to occur some variation in the results. In the specific situation of a study, there is the aggravation of multiple observations be conducted on the same day, so that fatigue could lead to inconsistent diagnoses. For this reason, only one patient per day received dental care with nitrous oxide (N2O). In light of the above considerations, two dentists were calibrated to evaluate behavior in Venham's Score.
Behavioral and the physiological parameters evaluations of patients referred for dental treatment were performed in four stages: pre-sedation, induction, sedated patient and in the end.
Measures of Heart Rate and Respiratory Rate were recorded in all time intervals. The Heart Rate was later corrected for physiological cardiac variability in the different age groups of patients.
- Conditions
- Cerebral Palsy
- Being tested
- Control of Stress
- Keywords
- Cerebral Palsy, Dental Care, Conscious Sedation, Autonomic Nervous System, Nitrous Oxide
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control of StressBehavioural
To control stress were measured (at different times: T1, T2, T3 and T4) Venham's Score, Heart Rate, Respiratory Rate, and the titration of gases.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Subjects | Experimental | Use of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy Receives: Behavioral: Control of Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Respiratory Rate
Measured: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Venham's Score
Measured: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Nitrous oxide and Oxygen Proportion
Measured: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cruzeiro do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Fernando Martins Baeder, Universidade Cruzeiro do Sul
- Investigators
- Fernando M Baeder, PhD, Principal investigator, Universidade Cruzeiro do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322983
- Sponsor's protocol ID
- 3307801700P7
- Other IDs
- CE/UCS - 044/2010
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT02322983
- Acronym / sponsor ID
- 3307801700P7
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Dental Care, Conscious Sedation, Autonomic Nervous System, Nitrous Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universidade Cruzeiro do SulUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral Palsy induces oral alterations that impact on oral health, requiring dental treatment. The objective of this study was to evaluate the use of conscious sedation with nitrous oxide (N2O) in the control of stress during dental treatment in individuals with Cerebral Palsy.
Detailed description
Were invited and accepted to participate in this study, 77 individuals with Cerebral Palsy who attended the outpatient clinic of San Francisco Home School (SFHS) at the time of data collection.
This study served as a non-randomized experimental trial conducted between 2011/2012 at dental ambulatory in the SFHS. Dental care routines have been established, by standardizing procedures and ensuring the reproducibility of the method of sedation. In the initial consultation, medical history taking (collecting sociodemographic data of the participants) and dental examination was performed. Data relating to the Cerebral Palsy clinical standard were collected from medical records of patients and noted in the evaluation sheet developed specifically for this research. Were provided to guardians the clarifications regarding sedation technique and treatment planning.
At dental examination the diagnostic criteria of caries followed those proposed by the World Health Organization (WHO). On the second visit, the patient was stabilized in the dental chair under mechanical contention. Performed adaptation and selection of nasal mask, monitoring equipment were positioned, starting the observation and recording of the behavioral and physiological records in the evaluation sheets. The proportion of gas was manipulated relative to the percentage between nitrous oxide and oxygen to achieve optimal sedation. In this study, it was considered a good sedation for Cerebral Palsy patient when he showed a certain degree of relaxation, which becomes more cooperative with treatment.
Behavioral assessment in relation to dental treatment was measured by Venham's Score, standard used for behavioral assessment of the dental patient, and the measurement performed according to the patient's behavior during the dental procedure.
Due to the subjectivity which compose the diagnosis of diseases or behavior analysis, it is common to occur some variation in the results. In the specific situation of a study, there is the aggravation of multiple observations be conducted on the same day, so that fatigue could lead to inconsistent diagnoses. For this reason, only one patient per day received dental care with nitrous oxide (N2O). In light of the above considerations, two dentists were calibrated to evaluate behavior in Venham's Score.
Behavioral and the physiological parameters evaluations of patients referred for dental treatment were performed in four stages: pre-sedation, induction, sedated patient and in the end.
Measures of Heart Rate and Respiratory Rate were recorded in all time intervals. The Heart Rate was later corrected for physiological cardiac variability in the different age groups of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy Subjects | Experimental | Behavioral: Control of StressUse of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Cerebral Palsy medical diagnosis;
- Age over 3 years old without distinction by gender;
- Patients with any clinical patterns of Cerebral Palsy;
- Patients with caries in at least two molars (primary or permanent), indicating anesthetic use for performing the restorative procedure.
Key exclusion criteria (3 listed)
- Patients with chronic respiratory problems (such as chronic bronchitis, COPD) or acute (like flu with nasal congestion and active pneumonia) as these conditions contraindicate the use of N2O;
- Cerebral Palsy patients with genetic syndromes associated;
- Patients whose caregivers refused to sign the Instrument of Consent and the Consent of the Use of Conscious Sedation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control of StressTo control stress were measured (at different times: T1, T2, T3 and T4) Venham's Score, Heart Rate, Respiratory Rate, and the titration of gases. | Behavioural | Cerebral Palsy Subjects |
Primary outcome
Heart Rate
Time frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Respiratory Rate
Time frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Venham's Score
Time frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Nitrous oxide and Oxygen Proportion
Time frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando M Baeder, PhD principal investigator
Universidade Cruzeiro do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cerebral Palsy, run by Universidade Cruzeiro do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.