Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433141
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-29
First Post:
2024-05-12
Brief Title:
Evaluation of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Evaluation of Clinical Performance Parents Satisfaction Gingival Health and Bacterial Effects of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars A Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study will be conducted to evaluate clinical performance parents satisfaction gingival health and bacterial effects of Bioflex crowns Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars
Detailed Description:
Intervention Pulptomy Procedures The tooth will be anaesthetized Then it will be isolated using a rubber dam Caries will be removed with a sterile non-end cutting bur 558 to complete the removal of the pulp chamber roof under copious water coolant spray Coronal pulp tissue remnants will be removed with a sharp sterile excavator A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes After removing the formocresol pellet a thick mix of zinc- oxideeugenol paste will be packed into the pulp chamber to seal the orifices
Restoration of the tooth
According to the groups restoration will be as the following
Group A Endocrowns tooth preparation scanning cementation
For the endocrowns A layer of light -cured glass ionomer cement of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core
Round-end tapered stone will be used to achieve depth cuts of 15 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line
Tapered stone of 8-degree angle will be used to prepare axial wall flared the pulp chamber walls to a standard degree of divergence
Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation
Endocrown will be manufactured using CADCAM technology internal wall of crown will be treated with etchant material rinsed dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation Group B Preformed Bioflex crowns
According to manufacturer instruction the preparation will be as the follow
Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected
Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-15 mm including the central groove
The proximal preparation will be around 05 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hovers plier
Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer
Group C performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation
A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected
A diamond bur will reduce the occlusal surface by 15-2 mm Interproximal contacts will be prepared with a tapered fissure bur About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked The passive fit of the crown will be assessed and will be luted with glass ionomer cement
Consistent firm finger pressure will be applied during cementation Observations
Clinical Performance Assessment Retention marginal adaption fracture of the restoration were scored using a modified United States Public Health Service USPHS criterion
Dental plaque accumulation and gingival condition were assessed using plaque index PI and GI
Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation
Clinical performance and oral status will be assessed at follow-up periods of 3 T1 6 T2 and 12 T3 months At the end of the follow-up T3 parents satisfaction analysis toward the color shape and size of three restorations will be adopted to directly evaluate their satisfaction toward their childrens restorations Parents responses were rated on a 5-point Likert-type scaleMicrobiological analysis
The swabs will be collected before preparation of crowns 3 months 6 months and 12 months after cementation The number of Streptococcus Mutans lactobacillus will be digitally counted Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans lactobacillus will be digitally counted Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium All specimens were transported immediately to microbiological lab
Restoration of the tooth
According to the groups restoration will be as the following
Group A Endocrowns tooth preparation scanning cementation
For the endocrowns A layer of light -cured glass ionomer cement of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core
Round-end tapered stone will be used to achieve depth cuts of 15 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line
Tapered stone of 8-degree angle will be used to prepare axial wall flared the pulp chamber walls to a standard degree of divergence
Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation
Endocrown will be manufactured using CADCAM technology internal wall of crown will be treated with etchant material rinsed dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation Group B Preformed Bioflex crowns
According to manufacturer instruction the preparation will be as the follow
Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected
Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-15 mm including the central groove
The proximal preparation will be around 05 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hovers plier
Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer
Group C performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation
A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected
A diamond bur will reduce the occlusal surface by 15-2 mm Interproximal contacts will be prepared with a tapered fissure bur About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked The passive fit of the crown will be assessed and will be luted with glass ionomer cement
Consistent firm finger pressure will be applied during cementation Observations
Clinical Performance Assessment Retention marginal adaption fracture of the restoration were scored using a modified United States Public Health Service USPHS criterion
Dental plaque accumulation and gingival condition were assessed using plaque index PI and GI
Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation
Clinical performance and oral status will be assessed at follow-up periods of 3 T1 6 T2 and 12 T3 months At the end of the follow-up T3 parents satisfaction analysis toward the color shape and size of three restorations will be adopted to directly evaluate their satisfaction toward their childrens restorations Parents responses were rated on a 5-point Likert-type scaleMicrobiological analysis
The swabs will be collected before preparation of crowns 3 months 6 months and 12 months after cementation The number of Streptococcus Mutans lactobacillus will be digitally counted Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans lactobacillus will be digitally counted Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium All specimens were transported immediately to microbiological lab
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