Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546826
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Alveolar Ridge Preservation After Tooth Extraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Alveolar Ridge Preservation with Several Techniques a Multicenter Observational Longitudinal Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRES-PRES
Brief Summary:
Post-extractive alveolar ridge remodeling represents a physiological phenomenon that may hamper successive implant insertion Several techniques have been proposed without any significant difference of efficacy among them Moreover several research protocols of analysis have been proposed including histomorphometric radiological clinical analysis
The purpose of the present study is to test different alveolar ridge preservation techniques using histomorphometric and optical scanning analysis
The purpose of the present study is to test different alveolar ridge preservation techniques using histomorphometric and optical scanning analysis
Detailed Description:
Primary objective The primary objective of the study is to clinically compare the effect on the preservation of the alveolar ridge of the use of dental roots in association with platelet rich fibrin compared to other regenerative techniques such as Ice Cream Cone Technique
Secondary objective The secondary objective is the collection of histological and histomorphometric data that allow to evaluate the quality and quantity of newly formed bone
Study design Multicenter observational study of a prospective non-profit cohort
List of centers involved in addition to our facility
- University of Porto Faculty of Dentistry Specialization in Periodontology and Implantology
Study population The study will be conducted in an outpatient hospital setting
Number of patients to be enrolled 32 patients among all the centers involved of which 16 patients in the University of Porto and 16 patients in University of Trieste center including dropouts
Enrollment procedure All patients who meet the inclusion and exclusion criteria will be enrolled in the study following the administration of the Information Sheet and the acquisition of informed consent
The choice of the alveolar ridge preservation protocol will be motivated by the clinician39s experience and the patient39s preference among those currently validated ice-cream cone technique tooth root etc
Under local anesthesia a trapezoidal mucoperiosteal flap extended to adjacent teeth mesially and distally will be raised to expose the defect and remove granulation tissue The dental root graft will be obtained by sectioning the extracted tooth at the cementoenamel junction and then separating the root longitudinally to fully expose the pulp chamber using a tungsten carbide bur with irrigation The specimen will then be thoroughly cleaned using manual curettes on the external surface while the removal of residual pulp tissue andor root canal filling material will be performed using a tungsten carbide bur with irrigation The tooth root specimen will be resized to fit the height and width of the post-extraction site to be regenerated and fixed using one to two titanium osteosynthesis screws A blood sample will then be collected in two sterile glass-lined plastic tubes and processed to produce a platelet rich fibrin membrane The blood sample will be centrifuged 2700 rpm for 12 minutes The platelet rich fibrin will then be removed from the tubes and placed on the surgical site Periosteal releasing incisions will be made to advance the mucoperiosteal flap which will be repositioned coronally and secured with horizontal mattress sutures and single stitches to ensure a submerged healing condition
In patients who will be treated using the Ice Cream Cone technique under local anesthesia the compromised tooth will be extracted atraumatically without raising a flap A resorbable collagen membrane will be shaped into a cone and inserted into the socket into which the xenograft will be placed mattress sutures will then be placed
For all patients after 26 weeks of healing a mucoperiosteal flap will be raised to expose the target site and a titanium implant will be inserted During this phase using a core drill to prepare the implant site it will also be functional to obtain a bone sample that will be subsequently analyzed
Study Outcomes
The primary endpoint is the width of the alveolar ridge which will be assessed in two stages
T0 initial condition of the alveolar ridge measured before performing surgery
T1 final condition of the alveolar ridge measured before implant insertion at 26 weeks of healing from surgery
The primary endpoint will be classified as follows The secondary endpoints are represented by histomorphometric variables newly formed mineralized tissue New boneTotal volume graft residues RGTV newly formed non-mineralized tissue Nonmineralised tissueTotal volume total mineralized tissue that will be assessed at twenty-six weeks of healing Mineralised tissuetotal volume evaluated as means and standard deviations and with χ2 test
The primary endpoint will then be assessed in relation to complications and adverse events such as
Soft tissue dehiscence
Graft exposure
Graft loss
Wound infections
The width of the alveolar ridge will be measured linearly and volumetrically using digital scans processed by a 3D scanning software Geomagic Control X 3D System Morrisville USA at the University of Trieste
The data collected at follow-up and the outcome data are based on a clinical evaluation considering the possible presence of complications and adverse events
The histological and histomorphometric analysis of all samples will be performed by one of the authors blinded to the study design and the origin of the biopsy The biopsies left inside the core drills to maintain the orientation of the bone core will be rinsed with a cold 5 glucose solution to remove blood residues while maintaining the correct osmolarity 278 mOsmL The samples will then be fixed for 3 days in a 10 buffered formalin solution at pH 72 and then processed for histological and histomorphometric evaluation at the Bone Lab University of Trieste After this the samples will be delivered to specialized and authorized companies for disposal according to current legislation
Collected data variables and sources
The following variables will be collected for each enrolled patientparticipant
Width of the alveolar ridge
Newly formed mineralized tissue graft residues non-mineralized newly formed tissue total mineralized tissue
Histological and histomorphometric analysis of all samples will be performed by one of the authors blinded to the study design and biopsy origin Biopsies left inside the core drills to maintain the orientation of the bone core will be rinsed with a cold 5 glucose solution to remove blood residues while maintaining the correct osmolarity 278 mOsmL Samples will then be fixed for 3 days in a 10 buffered formalin solution at pH 72 and then dehydrated in ascending series of alcohol rinses After 5 days of preinfiltration in a 50 resinalcohol solution biopsies will be removed from the core drills and sample infiltration will be completed with methacrylate resin After 12 days of polymerization the samples will be cut along their longitudinal axis using a high-precision silicon carbide disc at 50 μm and then finished under running water with a series of polishing discs at approximately 30 10 μm They will then be mounted on slides and stained with acid fuchsin toluidine blue and Von Kossa
Following histological and histomorphometric analyses the samples will be delivered to specialized and authorized companies for disposal according to current legislation
Statistical plan The statistical analysis will be performed by means of a computerized statistical package SigmaStat 35 SPSS Inc Germany The data will be expressed as mean standard deviation and median interquartile range respectively for parametric and non-parametric values
Sample size calculation The aim of the study is to clinically compare the effect on alveolar ridge preservation of the use of dental roots in association with platelet rich fibrin compared to the Ice Cream Cone Technique
It will be necessary to recruit sixteen patients to obtain a statistically significant result through a comparison between subpopulations with a statistical power of 95 and a significance of 005
This hypothesized sample size is in line with the expected number for our center where in the last 5 years we have had an average population of 4300 patients undergoing tooth extraction each year of which 150 may have aspired to implant insertion and estimating at least 40 with alveolar bone defect as deduced from the literature we can theoretically have 34 patients eligible for enrollment per year
Secondary objective The secondary objective is the collection of histological and histomorphometric data that allow to evaluate the quality and quantity of newly formed bone
Study design Multicenter observational study of a prospective non-profit cohort
List of centers involved in addition to our facility
- University of Porto Faculty of Dentistry Specialization in Periodontology and Implantology
Study population The study will be conducted in an outpatient hospital setting
Number of patients to be enrolled 32 patients among all the centers involved of which 16 patients in the University of Porto and 16 patients in University of Trieste center including dropouts
Enrollment procedure All patients who meet the inclusion and exclusion criteria will be enrolled in the study following the administration of the Information Sheet and the acquisition of informed consent
The choice of the alveolar ridge preservation protocol will be motivated by the clinician39s experience and the patient39s preference among those currently validated ice-cream cone technique tooth root etc
Under local anesthesia a trapezoidal mucoperiosteal flap extended to adjacent teeth mesially and distally will be raised to expose the defect and remove granulation tissue The dental root graft will be obtained by sectioning the extracted tooth at the cementoenamel junction and then separating the root longitudinally to fully expose the pulp chamber using a tungsten carbide bur with irrigation The specimen will then be thoroughly cleaned using manual curettes on the external surface while the removal of residual pulp tissue andor root canal filling material will be performed using a tungsten carbide bur with irrigation The tooth root specimen will be resized to fit the height and width of the post-extraction site to be regenerated and fixed using one to two titanium osteosynthesis screws A blood sample will then be collected in two sterile glass-lined plastic tubes and processed to produce a platelet rich fibrin membrane The blood sample will be centrifuged 2700 rpm for 12 minutes The platelet rich fibrin will then be removed from the tubes and placed on the surgical site Periosteal releasing incisions will be made to advance the mucoperiosteal flap which will be repositioned coronally and secured with horizontal mattress sutures and single stitches to ensure a submerged healing condition
In patients who will be treated using the Ice Cream Cone technique under local anesthesia the compromised tooth will be extracted atraumatically without raising a flap A resorbable collagen membrane will be shaped into a cone and inserted into the socket into which the xenograft will be placed mattress sutures will then be placed
For all patients after 26 weeks of healing a mucoperiosteal flap will be raised to expose the target site and a titanium implant will be inserted During this phase using a core drill to prepare the implant site it will also be functional to obtain a bone sample that will be subsequently analyzed
Study Outcomes
The primary endpoint is the width of the alveolar ridge which will be assessed in two stages
T0 initial condition of the alveolar ridge measured before performing surgery
T1 final condition of the alveolar ridge measured before implant insertion at 26 weeks of healing from surgery
The primary endpoint will be classified as follows The secondary endpoints are represented by histomorphometric variables newly formed mineralized tissue New boneTotal volume graft residues RGTV newly formed non-mineralized tissue Nonmineralised tissueTotal volume total mineralized tissue that will be assessed at twenty-six weeks of healing Mineralised tissuetotal volume evaluated as means and standard deviations and with χ2 test
The primary endpoint will then be assessed in relation to complications and adverse events such as
Soft tissue dehiscence
Graft exposure
Graft loss
Wound infections
The width of the alveolar ridge will be measured linearly and volumetrically using digital scans processed by a 3D scanning software Geomagic Control X 3D System Morrisville USA at the University of Trieste
The data collected at follow-up and the outcome data are based on a clinical evaluation considering the possible presence of complications and adverse events
The histological and histomorphometric analysis of all samples will be performed by one of the authors blinded to the study design and the origin of the biopsy The biopsies left inside the core drills to maintain the orientation of the bone core will be rinsed with a cold 5 glucose solution to remove blood residues while maintaining the correct osmolarity 278 mOsmL The samples will then be fixed for 3 days in a 10 buffered formalin solution at pH 72 and then processed for histological and histomorphometric evaluation at the Bone Lab University of Trieste After this the samples will be delivered to specialized and authorized companies for disposal according to current legislation
Collected data variables and sources
The following variables will be collected for each enrolled patientparticipant
Width of the alveolar ridge
Newly formed mineralized tissue graft residues non-mineralized newly formed tissue total mineralized tissue
Histological and histomorphometric analysis of all samples will be performed by one of the authors blinded to the study design and biopsy origin Biopsies left inside the core drills to maintain the orientation of the bone core will be rinsed with a cold 5 glucose solution to remove blood residues while maintaining the correct osmolarity 278 mOsmL Samples will then be fixed for 3 days in a 10 buffered formalin solution at pH 72 and then dehydrated in ascending series of alcohol rinses After 5 days of preinfiltration in a 50 resinalcohol solution biopsies will be removed from the core drills and sample infiltration will be completed with methacrylate resin After 12 days of polymerization the samples will be cut along their longitudinal axis using a high-precision silicon carbide disc at 50 μm and then finished under running water with a series of polishing discs at approximately 30 10 μm They will then be mounted on slides and stained with acid fuchsin toluidine blue and Von Kossa
Following histological and histomorphometric analyses the samples will be delivered to specialized and authorized companies for disposal according to current legislation
Statistical plan The statistical analysis will be performed by means of a computerized statistical package SigmaStat 35 SPSS Inc Germany The data will be expressed as mean standard deviation and median interquartile range respectively for parametric and non-parametric values
Sample size calculation The aim of the study is to clinically compare the effect on alveolar ridge preservation of the use of dental roots in association with platelet rich fibrin compared to the Ice Cream Cone Technique
It will be necessary to recruit sixteen patients to obtain a statistically significant result through a comparison between subpopulations with a statistical power of 95 and a significance of 005
This hypothesized sample size is in line with the expected number for our center where in the last 5 years we have had an average population of 4300 patients undergoing tooth extraction each year of which 150 may have aspired to implant insertion and estimating at least 40 with alveolar bone defect as deduced from the literature we can theoretically have 34 patients eligible for enrollment per year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None