Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867862
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2023-01-23
Brief Title:
Implementation of a Program to Strengthen Oral Hygiene in Patient With Cleft Deformities
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Implementation of a Program to Strengthen Oral Hygiene in Patient With Cleft Deformities HBD-Fentes
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBD-Fentes
Brief Summary:
A thorough analysis of the literature shows that children with clefts have a lesser oral hygiene OH and dental health DH than children without facial malformations which leads to an increased number of tooth decay on temporary and permanent tooth and a poor gingival health due to gingivitis or periodontitis The incidence of tooth decay is corelated with the severity of the cleft children with bilateral cleft lip including the alveolar bone have a higher rate of tooth decay Despite the fact that carious lesions are decreasing in general population its rate remain constant in children with cleft
Children who suffer from cleft in the north-west region of France are treated within the center of competence of rare disorder in the Nantess hospital CCMR MAFACE this center is a gathering of different professional health specialist surgeon speech specialist gynecologist orthodontists pediatrician working together to maximize treatment for those patients from diagnosis sometime antenatal to adulthood
The active file of patients treated for cleft in Nantess CHU is quite important allowing an easy recruitment
The investigator would like to create a clinical study assessing the impact implementing a special program to strengthen OH in patient with cleft whose follow-up is taking place in Nantess CCMR MAFACE It would be an epidemiologic prospective randomized controlled and monocentric study
Children who suffer from cleft in the north-west region of France are treated within the center of competence of rare disorder in the Nantess hospital CCMR MAFACE this center is a gathering of different professional health specialist surgeon speech specialist gynecologist orthodontists pediatrician working together to maximize treatment for those patients from diagnosis sometime antenatal to adulthood
The active file of patients treated for cleft in Nantess CHU is quite important allowing an easy recruitment
The investigator would like to create a clinical study assessing the impact implementing a special program to strengthen OH in patient with cleft whose follow-up is taking place in Nantess CCMR MAFACE It would be an epidemiologic prospective randomized controlled and monocentric study
Detailed Description:
Clef are congenital defects of the oral sphere there are different types of cleft regarding the cleft of the primary palate the investigator can find the cleft lips that are either uni ou bi laterals and can affect the nostrils and or the alveolar bone the clefs of the secondary palate are velar clefs clefts of the palate or both meaning they affect the hard palate and soft palate
Clefts accounts for 1 in 800 birth 1 A thorough analysis of the literature shows that children with clefts have a lesser oral hygiene OH and dental health DH than children without facial malformations which leads to an increased number of tooth decay on temporary and permanent tooth and a poor gingival health due to gingivitis or periodontitis The incidence of tooth decay is corelated with the severity of the cleft children with bilateral cleft lip including the alveolar bone have a higher rate of tooth decay Despite the fact that carious lesions are decreasing in general population its rate remain constant in children with cleft
A systemic revue looking for solutions or special therapy that could exists in order to optimized the oral health and dental status of cleft patient conclude that there is a real necessity to maximized their treatment but few studies focus on preventive strategies or the development of tools to make OH easier for those patients
Children who suffer from cleft in the north-west region of France are treated within the center of competence of rare disorder in the Nantess hospital CCMR MAFACE this center is a gathering of different professional health specialist surgeon speech specialist gynecologist orthodontists pediatrician working together to maximize treatment for those patients from diagnosis sometime antenatal to adulthood
The active file of patients treated for cleft in Nantess CHU is quite important allowing an easy recruitment
The investigatoir would like to create a clinical study assessing the impact implementing a special program to strengthen OH in patient with cleft whose follow-up is taking place in Nantess CCMR MAFACE It would be an epidemiologic prospective randomized controlled and monocentric study
The main goal of this study is to assess the effects of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their OH status
The primary criteria will be the evolution of the dental index which is the DMF index dmftDMFT There are numerous secondary objectives that will result from the data driven analysis during the consultations they will not lengthen the duration of the consultation and neither add extra interventions on the patient
Assess the contribution of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their gingival status
Assess the satisfaction of the dental care and the follow-ups by the patients and the parents
Assess the accessibility to dental care for children with cleft
Assess the impact of familial eating and hygiene habits on OH and its evolution during the year of follow-up
Assess the influence of orthodontics appliance syndromes and other conditions related to the cleft malocclusion bucco-nasal fistulas dental anomalies sweet medications and medication inducing hyposialie on tooth decay
Assess preferential localization of tooth decay
Assess the financial impact of this protocol
Children with a cleft lip and or palate uni ou bilateral between the age of 3 and 15 years old coming to the CCMR MAFACE for treatment will be offered the possibility to participate to this study
If they accept they will be randomly assigned to 2 different groups
For the control group the instructions regarding OH given to the children and their parents will be the same than the one usually given by the maxilla-facial surgeons or the orthodontists during their annual follow-up visits If the patients are in need of dental care they will be encouraged to contact their dentist
For the test group a consultation of 30 to 45 minutes will be added to the annual visit with a dentist During this consultation the children will be incited to have a better OH oral explanations will be provided as well as written ones The goal is to have the best understanding of the importance of good OH and brushing technique from the children and the parents
If dental treatments are needed they will be done in the same time or they will be programmed for another time at de the center of dental car of the hospital CSD
Patient in the test groups will also have tele-consultations every 2 months in order to try and keep the child motivation to a maximum and also assess the OH of the patient they will also have an extra consultation with the dentist at 6 months
Regarding the primary objective the 2 groups will have a carious record done at day 1 year 1 and year 2 the secondary objective will also be collected at those dates and for the test groups extra data will be collected at 2 month 4 month 6 month 8 month and 10 month
The number of necessary subjects was calculated using two different studies using the same criteria of judgement 54 patients are needed for this study 27 in each group
If the investigator can show a significant difference in the medical and dental care due to the implication of this program the goal would be to generalize this course of treatment to all the children with cleft within the service of maxillar-surgery CMF in Nantes and then once its a well-rounded system the investigators could implement this way of working nation wild
On a local scale this initiative and adding a regular dental consultation could allow the establishment of a day hospital for those patients and therefore it would be more comfortable for the patients and the parents
Clefts accounts for 1 in 800 birth 1 A thorough analysis of the literature shows that children with clefts have a lesser oral hygiene OH and dental health DH than children without facial malformations which leads to an increased number of tooth decay on temporary and permanent tooth and a poor gingival health due to gingivitis or periodontitis The incidence of tooth decay is corelated with the severity of the cleft children with bilateral cleft lip including the alveolar bone have a higher rate of tooth decay Despite the fact that carious lesions are decreasing in general population its rate remain constant in children with cleft
A systemic revue looking for solutions or special therapy that could exists in order to optimized the oral health and dental status of cleft patient conclude that there is a real necessity to maximized their treatment but few studies focus on preventive strategies or the development of tools to make OH easier for those patients
Children who suffer from cleft in the north-west region of France are treated within the center of competence of rare disorder in the Nantess hospital CCMR MAFACE this center is a gathering of different professional health specialist surgeon speech specialist gynecologist orthodontists pediatrician working together to maximize treatment for those patients from diagnosis sometime antenatal to adulthood
The active file of patients treated for cleft in Nantess CHU is quite important allowing an easy recruitment
The investigatoir would like to create a clinical study assessing the impact implementing a special program to strengthen OH in patient with cleft whose follow-up is taking place in Nantess CCMR MAFACE It would be an epidemiologic prospective randomized controlled and monocentric study
The main goal of this study is to assess the effects of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their OH status
The primary criteria will be the evolution of the dental index which is the DMF index dmftDMFT There are numerous secondary objectives that will result from the data driven analysis during the consultations they will not lengthen the duration of the consultation and neither add extra interventions on the patient
Assess the contribution of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their gingival status
Assess the satisfaction of the dental care and the follow-ups by the patients and the parents
Assess the accessibility to dental care for children with cleft
Assess the impact of familial eating and hygiene habits on OH and its evolution during the year of follow-up
Assess the influence of orthodontics appliance syndromes and other conditions related to the cleft malocclusion bucco-nasal fistulas dental anomalies sweet medications and medication inducing hyposialie on tooth decay
Assess preferential localization of tooth decay
Assess the financial impact of this protocol
Children with a cleft lip and or palate uni ou bilateral between the age of 3 and 15 years old coming to the CCMR MAFACE for treatment will be offered the possibility to participate to this study
If they accept they will be randomly assigned to 2 different groups
For the control group the instructions regarding OH given to the children and their parents will be the same than the one usually given by the maxilla-facial surgeons or the orthodontists during their annual follow-up visits If the patients are in need of dental care they will be encouraged to contact their dentist
For the test group a consultation of 30 to 45 minutes will be added to the annual visit with a dentist During this consultation the children will be incited to have a better OH oral explanations will be provided as well as written ones The goal is to have the best understanding of the importance of good OH and brushing technique from the children and the parents
If dental treatments are needed they will be done in the same time or they will be programmed for another time at de the center of dental car of the hospital CSD
Patient in the test groups will also have tele-consultations every 2 months in order to try and keep the child motivation to a maximum and also assess the OH of the patient they will also have an extra consultation with the dentist at 6 months
Regarding the primary objective the 2 groups will have a carious record done at day 1 year 1 and year 2 the secondary objective will also be collected at those dates and for the test groups extra data will be collected at 2 month 4 month 6 month 8 month and 10 month
The number of necessary subjects was calculated using two different studies using the same criteria of judgement 54 patients are needed for this study 27 in each group
If the investigator can show a significant difference in the medical and dental care due to the implication of this program the goal would be to generalize this course of treatment to all the children with cleft within the service of maxillar-surgery CMF in Nantes and then once its a well-rounded system the investigators could implement this way of working nation wild
On a local scale this initiative and adding a regular dental consultation could allow the establishment of a day hospital for those patients and therefore it would be more comfortable for the patients and the parents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None