Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746482
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-01-31
Brief Title:
Retrospective Assessment of Root Canal Retreatment Performed in Single Visit
Sponsor:
Dubai Health Authority
Organization:
Dubai Health Authority
Study Overview
Official Title:
Outcome of Root Canal Retreatment Performed in Single Visits A Retrospective Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
In cases refractory to initial root canal therapy in which a decision is made to perform nonsurgical retreatment the patient has the right to know the prognosis of the proposed treatment and clinicians must be able to provide this information based on the best available data The literature answered this question when the treatment was performed in multiple visits however little information exists when single visit root canal retreatment was performed Therefore the aim of the present study is to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority DHA
Detailed Description:
The present study is designed to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority DHA This is a retrospective study where patients treatment data will be collected and outcome criteria will be applied blindly
The sample in this retrospective study will be selected from those patients who have undergone single visit endodontic retreatment at the DHA Endodontics clinics from January 2018 through December 2019 The teeth under investigation will be tracked in the database starting from completion of retreatment for at least 6 months and the percentages of teeth that were retained or underwent additional procedures such as apical surgery or extraction will be recorded
The clinical and radiographic assessment at baseline and at recall documented in clinical notes and all data will be collected using a standardized proforma
The quality of the existing root canal fillings and the status of the periapical tissues will be determined according to the PAI by 2 calibrated independent observers using the periapical radiographs
A Periapical index PAI The index is a radiographic method of interpretation that consists of 5 categories numbered 1-5
B Quality of root canal filling
Three criteria were used to assess the quality of the existing root canal fillings as follows
Length of root canal filling root filling ending 2 mm from the radiographic apex root filling ending 2 mm from the radiographic apex or root filling at the radiographic apex flush
Density of root canal filling the presence or absence of voids in the root filling or between the root filling and root canal walls
Taper of the root canal filling consistent taper from the orifice to the apex or no consistent taper from the orifice to the apex
The preoperative diagnosis is determined based on clinical and radiographic findings using the American Association of Endodontists Consensus Conference-recommended diagnostic terminology
Retreatment Procedures
Endodontic retreatment of all cases was conducted in a single visit by endodontic specialists according to the contemporary standards of endodontic therapy
Only those patients with at least 6 months of clinical and radiographic follow-up were included When patients returned for recalls one or multiple in mutirooted teeth periapical radiographs were taken
Follow up
Recall appointments included a radiographic and clinical examination of the treated tooth The examination was documented and included any signs or symptoms the presence of a sinus tract sensitivity to percussion and palpation swelling periodontal pockets or a history of pain
Periapical radiographs will be evaluated by 2 examiners
The treatment outcomes will be classified into 3 categories according to the following definitions
Healed Functional asymptomatic teeth with no or minimal radiographic periradicular pathosis radiolucency Nonhealed Nonfunctional symptomatic teeth with or without radiographic periradicular pathosis or asymptomatic teeth with unchanged new or enlarged radiographic periradicular pathosis radiolucency Healing Teeth that are asymptomatic and functional with a decreased size of radiographic periradicular pathosis radiolucency
Collecting data into a recording sheet
The patients treatment data will be collected continuously for at least 6 months in the database and outcome criteria will applied blindly The teeth will be tracked in the database during the entire period
The sample in this retrospective study will be selected from those patients who have undergone single visit endodontic retreatment at the DHA Endodontics clinics from January 2018 through December 2019 The teeth under investigation will be tracked in the database starting from completion of retreatment for at least 6 months and the percentages of teeth that were retained or underwent additional procedures such as apical surgery or extraction will be recorded
The clinical and radiographic assessment at baseline and at recall documented in clinical notes and all data will be collected using a standardized proforma
The quality of the existing root canal fillings and the status of the periapical tissues will be determined according to the PAI by 2 calibrated independent observers using the periapical radiographs
A Periapical index PAI The index is a radiographic method of interpretation that consists of 5 categories numbered 1-5
B Quality of root canal filling
Three criteria were used to assess the quality of the existing root canal fillings as follows
Length of root canal filling root filling ending 2 mm from the radiographic apex root filling ending 2 mm from the radiographic apex or root filling at the radiographic apex flush
Density of root canal filling the presence or absence of voids in the root filling or between the root filling and root canal walls
Taper of the root canal filling consistent taper from the orifice to the apex or no consistent taper from the orifice to the apex
The preoperative diagnosis is determined based on clinical and radiographic findings using the American Association of Endodontists Consensus Conference-recommended diagnostic terminology
Retreatment Procedures
Endodontic retreatment of all cases was conducted in a single visit by endodontic specialists according to the contemporary standards of endodontic therapy
Only those patients with at least 6 months of clinical and radiographic follow-up were included When patients returned for recalls one or multiple in mutirooted teeth periapical radiographs were taken
Follow up
Recall appointments included a radiographic and clinical examination of the treated tooth The examination was documented and included any signs or symptoms the presence of a sinus tract sensitivity to percussion and palpation swelling periodontal pockets or a history of pain
Periapical radiographs will be evaluated by 2 examiners
The treatment outcomes will be classified into 3 categories according to the following definitions
Healed Functional asymptomatic teeth with no or minimal radiographic periradicular pathosis radiolucency Nonhealed Nonfunctional symptomatic teeth with or without radiographic periradicular pathosis or asymptomatic teeth with unchanged new or enlarged radiographic periradicular pathosis radiolucency Healing Teeth that are asymptomatic and functional with a decreased size of radiographic periradicular pathosis radiolucency
Collecting data into a recording sheet
The patients treatment data will be collected continuously for at least 6 months in the database and outcome criteria will applied blindly The teeth will be tracked in the database during the entire period
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