Trauma DentalNCT03720925
Traumatic Dental Injuries Treatment and Oral Health Related to Quality of Life
A study testing TDI treatment in people with Trauma Dental and Quality of Life, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The aim of this research was to assess the impact of Oral Health-Related Quality of Life (OHRQoL) on children and their families affected by Traumatic Dental Injury (TDI) after insertion into a Dental Trauma Care Program (DTCP). Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Dental, Quality of Life
- What is being tested?
- TDI treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2013to 1 Dec 2019
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged from 2 to 6 years who suffered some type of TDI in the deciduous dentition
- healthy patients without disabilities
- children don't used interceptive orthodontic braces or prostheses
- TDI that occurred in the last 3 months before the first questionnaire application
- TDI treatment completed up to 3 months before the second questionnaire application
Who cannot join
- parents/caregivers that refuse to answer the questionnaire at any point
- parents/caregiversor who do not agree to sign the consent terms
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Nova Friburgo, Rio de Janeiro, 28625650
About this study
Official title: Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families
The aim of this research was to assess the impact of Oral Health-Related Quality of Life (OHRQoL) on children and their families affected by Traumatic Dental Injury (TDI) after insertion into a Dental Trauma Care Program (DTCP). After a sample size calculation, this non-randomized clinical study was composed of a consecutive sample of 2 to 6-year-old children registered in the DTCP from 2012-2019. Parents/Caregivers were interviewed to fill up an OHRQoL questionnaire. The Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) was applied (in form of an interview) to evaluate the impact of TDI on OHRQoL before, and after treatment. The scores of the B-ECOHIS were calculated using the additive method, summing the numeric response codes for each item. The Andreassen classification was used to determine the TDI. The patients were treated (minimally intervention/invasive intervention) according to TDI severity (uncomplicated/complicated). The Kolmogorov-Smirnov test was performed to evaluate the normality of the data to determine the use of parametric or non-parametric tests. Mean or median comparisons were made for items in the overall scale and subscale scores to compare B-ECOHIS total scale/subscales/domains before and after insertion in DTCP. The responsiveness was assessed by analyzing the change in the scores on the scales and subscales. The changes were calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration. TDI severity and treatment-associated were also evaluated.
Read the detailed description
It is recognized that measurements OHRQoL are essential strategies of oral health surveys, clinical trials, and studies evaluating the outcomes of preventive and therapeutic program. In the literature it is observed efficacy on OHRQoL outcomes focused on oral health education (OHE) associated to: atraumatic restorative treatment (ART), dental caries, gingivitis.
In the literature it is also seen that the presence of TDI is associated to negative impact on OHRQoL)that affects physical and psychosocial consequences for children and their families. The treatment of TDI is a challenge, that it is related to an improvement on famil and on children from 8 to 14 years and attended in a center of surveillance for TDI.
For a broader understanding of the consequences of outcomes of preventive and therapeutic program for TDI, it is important to expand the assessment of its performance using an OHRQoL measure for other ages of children.
- Conditions
- Trauma Dental, Quality of Life
- Being tested
- TDI treatment
- Keywords
- oral heath, quality of life, tooth injuries, children, family
- Medical subject headings
- Tooth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDI treatmentProcedure or surgery
The TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints).
| Study group | Role | What they receive |
|---|---|---|
| TDI treatment | Experimental | The TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints).
The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and from between 3 to 6 months after the TDI treatment . Receives: Procedure: TDI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
The B-ECOHIS was applied (in form of interview). This questionnaire is composed of 13 items distributed between a child impact section (CIS) and family impact section (FIS). The first section has four subscales: symptoms, function, psychology and self-image/social interaction. The FIS has two subscales: parental distress and family function. Response categories of ECOHIS were coded on a five-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. All 'don't know' responses were recoded to "never". The score for each domain is calculated through a simple sum of the scores of each item. The total score ranges from 0 to 52. After the TDI treatment a follow-up will be performed. The changes were calculated by subtracting the appointment 2 (follow up) from the appointment 1 (initial exam). Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration.
Measured: 6 months
Secondary outcomes (1)
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries according TDI severity and type of TDI treatment evaluated by B-ECOHIS instrument
The B-ECOHIS was applied (in form of interview)and was used to evaluate the impact of the TDI according to its severity (complicated or uncomplicated) and type of treatment (minimally invasive or invasive). This questionnaire is composed of 13 items distributed between a child impact section (CIS) and family impact section (FIS). The first section has four subscales: symptoms, function, psychology and self-image/social interaction. The FIS has two subscales: parental distress and family function. Response categories of ECOHIS were coded on a five-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. All 'don't know' responses were recoded to "never". The score for each domain is calculated through a simple sum of the scores of each item. The total score ranges from 0 to 52, with higher scores denoting greater oral health impact and poorer OHRQoL.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Mar 2013
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma DentalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Azeredo Alves Antunes, Universidade Federal Fluminense
- Investigators
- Livia A Antunes, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720925
- Sponsor's protocol ID
- TDI treatment and OHRQoL
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2018
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families
- ClinicalTrials.gov ID
- NCT03720925
- Acronym / sponsor ID
- TDI treatment and OHRQoL
- Conditions
- Trauma Dental, Quality of Life
- Keywords
- oral heath, quality of life, tooth injuries, children, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- 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.
The aim of this research was to assess the impact of Oral Health-Related Quality of Life (OHRQoL) on children and their families affected by Traumatic Dental Injury (TDI) after insertion into a Dental Trauma Care Program (DTCP). After a sample size calculation, this non-randomized clinical study was composed of a consecutive sample of 2 to 6-year-old children registered in the DTCP from 2012-2019. Parents/Caregivers were interviewed to fill up an OHRQoL questionnaire. The Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) was applied (in form of an interview) to evaluate the impact of TDI on OHRQoL before, and after treatment. The scores of the B-ECOHIS were calculated using the additive method, summing the numeric response codes for each item. The Andreassen classification was used to determine the TDI. The patients were treated (minimally intervention/invasive intervention) according to TDI severity (uncomplicated/complicated). The Kolmogorov-Smirnov test was performed to evaluate the normality of the data to determine the use of parametric or non-parametric tests. Mean or median comparisons were made for items in the overall scale and subscale scores to compare B-ECOHIS total scale/subscales/domains before and after insertion in DTCP. The responsiveness was assessed by analyzing the change in the scores on the scales and subscales. The changes were calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration. TDI severity and treatment-associated were also evaluated.
Detailed description
It is recognized that measurements OHRQoL are essential strategies of oral health surveys, clinical trials, and studies evaluating the outcomes of preventive and therapeutic program. In the literature it is observed efficacy on OHRQoL outcomes focused on oral health education (OHE) associated to: atraumatic restorative treatment (ART), dental caries, gingivitis.
In the literature it is also seen that the presence of TDI is associated to negative impact on OHRQoL)that affects physical and psychosocial consequences for children and their families. The treatment of TDI is a challenge, that it is related to an improvement on famil and on children from 8 to 14 years and attended in a center of surveillance for TDI.
For a broader understanding of the consequences of outcomes of preventive and therapeutic program for TDI, it is important to expand the assessment of its performance using an OHRQoL measure for other ages of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDI treatment | Experimental | Procedure: TDI treatmentThe TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints). The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and from between 3 to 6 months after the TDI treatment . |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged from 2 to 6 years who suffered some type of TDI in the deciduous dentition
- healthy patients without disabilities
- children don't used interceptive orthodontic braces or prostheses
- TDI that occurred in the last 3 months before the first questionnaire application
- TDI treatment completed up to 3 months before the second questionnaire application
Key exclusion criteria (2 listed)
- parents/caregivers that refuse to answer the questionnaire at any point
- parents/caregiversor who do not agree to sign the consent terms
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 |
|---|---|---|
| TDI treatmentThe TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints). | Procedure or surgery | TDI treatment |
Primary outcome
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
Time frame: 6 months
The B-ECOHIS was applied (in form of interview). This questionnaire is composed of 13 items distributed between a child impact section (CIS) and family impact section (FIS). The first section has four subscales: symptoms, function, psychology and self-image/social interaction. The FIS has two subscales: parental distress and family function. Response categories of ECOHIS were coded on a five-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. All 'don't know' responses were recoded to "never". The score for each domain is calculated through a simple sum of the scores of each item. The total score ranges from 0 to 52. After the TDI treatment a follow-up will be performed. The changes were calculated by subtracting the appointment 2 (follow up) from the appointment 1 (initial exam). Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration.
1 secondary outcome
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries according TDI severity and type of TDI treatment evaluated by B-ECOHIS instrument
Time frame: 6 months
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 30 Nov 2022.
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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.
Livia A Antunes, PhD principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDI treatment in people with Trauma Dental and Quality of Life, run by Universidade Federal Fluminense 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 5 inclusion and 2 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 30 Nov 2022. 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?
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument (time frame: 6 months). 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 30 Nov 2022.