Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353399
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-10-13
Brief Title:
Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Guided Bone Regeneration With and Without Use of Intra-marrow Penetrations A Prospective Human Clinical and Histologic Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The primary aims of this study are to compare after 6 months the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures
Detailed Description:
Study Design Twenty-four patients will be treated using the principles of guided bone generation utilizing full thickness flap for ridge augmentation Twelve test patients will receive guided bone regeneration with intra-marrow penetrations The positive control group of twelve patients will receive no intra-marrow penetrations Approximately six months post- surgery a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing
Presurgical Management Each patient will receive a diagnostic work-up including standardized radiographs periapical cone beam computed tomography CBCT scan study casts clinical photographs and a clinical examination to record attachment level probing depth recession and mobility of teeth adjacent to the extracted sites Presurgical preparation will include detailed oral hygiene instructions Baseline data will be collected just before the surgical phase of the treatment
Clinical Measurements
Baseline and 6-month data will include the following for edentulous area or adjacent teeth when necessary
1 Plaque index
2 Gingival index
3 Gingival margin levels Measured from cemento-enamel junction CEJ to the gingival margin
4 Keratinized tissue Measured from the gingival margin to the mucogingival junction
5 Clinical attachment level Measured from CEJ to the bottom of the clinical periodontal pocket
6 Clinical tooth mobility Measured by using the modified Millers Index
7 Ridge dimensions Pre-augmentation and six month healing
8 Soft tissue thickness
9 Radiographic examination including CBCT
10 Clinical photographs
Histologic Measurements
Measurements will be taken for augmented areas
Trephine core specimens will be evaluated to determine percent of residual graft particles newly formed bone bone marrow trabecular space and connective tissue Step serial sections will be taken from each longitudinally sectioned core The sections will be stained with hematoxylin and eosin Ten slides per patients will be prepared with at least 4 sections per slide For each patient 6 of 10 slides will be assessed The mean percentage of vital and nonvital bone and trabecular space will be determined for each patient by using an American Optical microscope at 150X with 10 X 10 ocular grid
Potential Risks
There are known physical risks linked with bone graft surgery The potential risks are the same as the risks of any minor surgery in the mouth These risks include
Infection of treated area usually mild rare less than 1
Mild bruising andor bleeding less likely 1-39
Mild swelling more than 40
Transient but occasional paresthesia or numbness of lips tongue chin or gum usually mild rare less than 1
Loss of the bone graft mild to moderate rare less than 1
There may also be additional risks that are currently unforeseeable
Adverse Events An adverse event refers to any adverse experience occurring during the clinical study period whether associated or not associated with the study test articles or procedures A serious adverse event means any experiences that suggest significant hazard contraindication side effect or precaution With respect to human clinical experience a serious adverse event includes any experience that is fatal or life threatening causes a persistent or permanent disability requires initial or prolonged hospitalization requires medical or surgical intervention to prevent permanent impairment or damage or is a congenital anomaly
An unanticipated adverse event is one that is not identified in nature severity or frequency
Adverse events will be monitored by observing and interviewing the subject during the study Subjects who experience any significant problems during the study are to call and discuss them with investigator Any suspected adverse event or allergic response is to be thoroughly examined by investigator All adverse events are to be reported All subjects experiencing adverse events will be followed by the investigator until there is a return to the subjects baseline condition or a clinically satisfactory resolution is achieved Adverse events that are serious or unanticipated are to be reported immediately by phone to the study director and promptly reported to the institutional review board IRB which will include the event date description of the adverse event study treatment involved and outcome of event Examples of expected but rarely occurring adverse events related to grafting treatment include clinical observation of infection flap necrosis severe inflammation severe pain loss of attachment of the gingival tissue to the tooth reaction to study materials and osteonecrosis
Measurement Techniques All probing measurements will be taken using the University of North Carolina probe A masked calibrated examiner will perform the initial examination and the measurements at the time of initial surgery The mentor will check these measurements Differences of more than 10 mm between examiners will be remeasured by the blinded examiner Measurements will again be repeated at the 6-month examination using the same techniques
Statistical Analysis Means and standard deviations will be calculated for all parameters A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data An unpaired t-test will be used to evaluate statistical differences between the test and control groups The sample size of 12 per group gives _80__ statistical power to detect a difference of 1 mm between groups Power calculations were based on data from previous studies
Research Materials Records and Privacy The de-identified data collected will be entered in an excel spreadsheet which will be password protected The data will be stored in an encrypted computer which is also password protected No one will have access to this data other than the individual collecting it and the PI No personal identifying information will be collected or needed for the study analytical purposes
Significance The results of this study will allow comparison of the effects of intra-marrow penetrations on guided ridge regeneration in terms of vertical and horizontal dimensions and histologic bone quality
The Plaque Index The modified OLeary plaque index plaque free sites will be used to obtain dichotomous plaque scores at 6 sites per tooth
The Gingival Index
The Gingival Index will be measured Scores will be as follows
0- Normal Gingiva
1 Mild inflammation slight change in color slight edema
2 Moderate inflammation redness edema glazing
3 Severe inflammation marked redness edema and ulceration
Each gingival unit mesio-buccal mid-buccal disto-buccal mesio-lingual mid-lingual and disto-lingual of the individual tooth will be given a score from 0-3 called the gingival index for the area The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth
Standardized Radiographic Technique The Rinn radiographic holder is positioned to allow as near as possible paralleling technique Radiographs will be taken at baseline and again at 6 months
Arithmetic Determinations
Change in horizontal ridge dimension Pre-op Width - Post-op Width
Change in vertical ridge dimension Pre-op Distance - Post-op Distance
Tooth mobility 0 - Mobility of the crown is within normal physiologic limits
1 Mobility of the crown up to 05 mm in one direction Does not exceed 10 mm in both directions
2 Mobility of the crown from 05 to 1 mm in one direction Does not exceed 20 mm in both directions
3 Mobility of the crown exceeding 1 mm in one direction andor vertical depressibility Greater than 20 mm in both directions andor vertical depressibility
Examiner calibration
The data will be compared from indices or measurements taken by the examiner on three different patients at two different times within a 60-minute period to measure the intra-examiner accuracy and reproducibility
A minimum of three subjects are to be recruited to participate in the calibration The subjects should exhibit a range of the criteria being assessed in the index or measurements being performed ie subjects with moderate to severe periodontal disease
The examiner will score 3 teeth per subject within the same quadrant The examiner will measure each subject calling out the measurements site by site while the assistant records
Duplicate measurements of the subjects will be taken within 60 minutes following the initial measurements The assistant will record the second set of data
The examiner will not compare the two sets of data at any time during the calibration The examiner will not discuss their measurements with the assistant or the subject during the calibration
The assistant recording the data will be responsible for handling the data sheets The examiner will have no access to any of the data sheets during the course of the calibration
The data sets will be analyzed for percent agreement Acceptable percent agreement will reflect the limits set for the different parameters measured
Acceptable percent agreement will be 90 within 1mm for probing depth recession and attachment level and 70 within 0 mm
Presurgical Management Each patient will receive a diagnostic work-up including standardized radiographs periapical cone beam computed tomography CBCT scan study casts clinical photographs and a clinical examination to record attachment level probing depth recession and mobility of teeth adjacent to the extracted sites Presurgical preparation will include detailed oral hygiene instructions Baseline data will be collected just before the surgical phase of the treatment
Clinical Measurements
Baseline and 6-month data will include the following for edentulous area or adjacent teeth when necessary
1 Plaque index
2 Gingival index
3 Gingival margin levels Measured from cemento-enamel junction CEJ to the gingival margin
4 Keratinized tissue Measured from the gingival margin to the mucogingival junction
5 Clinical attachment level Measured from CEJ to the bottom of the clinical periodontal pocket
6 Clinical tooth mobility Measured by using the modified Millers Index
7 Ridge dimensions Pre-augmentation and six month healing
8 Soft tissue thickness
9 Radiographic examination including CBCT
10 Clinical photographs
Histologic Measurements
Measurements will be taken for augmented areas
Trephine core specimens will be evaluated to determine percent of residual graft particles newly formed bone bone marrow trabecular space and connective tissue Step serial sections will be taken from each longitudinally sectioned core The sections will be stained with hematoxylin and eosin Ten slides per patients will be prepared with at least 4 sections per slide For each patient 6 of 10 slides will be assessed The mean percentage of vital and nonvital bone and trabecular space will be determined for each patient by using an American Optical microscope at 150X with 10 X 10 ocular grid
Potential Risks
There are known physical risks linked with bone graft surgery The potential risks are the same as the risks of any minor surgery in the mouth These risks include
Infection of treated area usually mild rare less than 1
Mild bruising andor bleeding less likely 1-39
Mild swelling more than 40
Transient but occasional paresthesia or numbness of lips tongue chin or gum usually mild rare less than 1
Loss of the bone graft mild to moderate rare less than 1
There may also be additional risks that are currently unforeseeable
Adverse Events An adverse event refers to any adverse experience occurring during the clinical study period whether associated or not associated with the study test articles or procedures A serious adverse event means any experiences that suggest significant hazard contraindication side effect or precaution With respect to human clinical experience a serious adverse event includes any experience that is fatal or life threatening causes a persistent or permanent disability requires initial or prolonged hospitalization requires medical or surgical intervention to prevent permanent impairment or damage or is a congenital anomaly
An unanticipated adverse event is one that is not identified in nature severity or frequency
Adverse events will be monitored by observing and interviewing the subject during the study Subjects who experience any significant problems during the study are to call and discuss them with investigator Any suspected adverse event or allergic response is to be thoroughly examined by investigator All adverse events are to be reported All subjects experiencing adverse events will be followed by the investigator until there is a return to the subjects baseline condition or a clinically satisfactory resolution is achieved Adverse events that are serious or unanticipated are to be reported immediately by phone to the study director and promptly reported to the institutional review board IRB which will include the event date description of the adverse event study treatment involved and outcome of event Examples of expected but rarely occurring adverse events related to grafting treatment include clinical observation of infection flap necrosis severe inflammation severe pain loss of attachment of the gingival tissue to the tooth reaction to study materials and osteonecrosis
Measurement Techniques All probing measurements will be taken using the University of North Carolina probe A masked calibrated examiner will perform the initial examination and the measurements at the time of initial surgery The mentor will check these measurements Differences of more than 10 mm between examiners will be remeasured by the blinded examiner Measurements will again be repeated at the 6-month examination using the same techniques
Statistical Analysis Means and standard deviations will be calculated for all parameters A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data An unpaired t-test will be used to evaluate statistical differences between the test and control groups The sample size of 12 per group gives _80__ statistical power to detect a difference of 1 mm between groups Power calculations were based on data from previous studies
Research Materials Records and Privacy The de-identified data collected will be entered in an excel spreadsheet which will be password protected The data will be stored in an encrypted computer which is also password protected No one will have access to this data other than the individual collecting it and the PI No personal identifying information will be collected or needed for the study analytical purposes
Significance The results of this study will allow comparison of the effects of intra-marrow penetrations on guided ridge regeneration in terms of vertical and horizontal dimensions and histologic bone quality
The Plaque Index The modified OLeary plaque index plaque free sites will be used to obtain dichotomous plaque scores at 6 sites per tooth
The Gingival Index
The Gingival Index will be measured Scores will be as follows
0- Normal Gingiva
1 Mild inflammation slight change in color slight edema
2 Moderate inflammation redness edema glazing
3 Severe inflammation marked redness edema and ulceration
Each gingival unit mesio-buccal mid-buccal disto-buccal mesio-lingual mid-lingual and disto-lingual of the individual tooth will be given a score from 0-3 called the gingival index for the area The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth
Standardized Radiographic Technique The Rinn radiographic holder is positioned to allow as near as possible paralleling technique Radiographs will be taken at baseline and again at 6 months
Arithmetic Determinations
Change in horizontal ridge dimension Pre-op Width - Post-op Width
Change in vertical ridge dimension Pre-op Distance - Post-op Distance
Tooth mobility 0 - Mobility of the crown is within normal physiologic limits
1 Mobility of the crown up to 05 mm in one direction Does not exceed 10 mm in both directions
2 Mobility of the crown from 05 to 1 mm in one direction Does not exceed 20 mm in both directions
3 Mobility of the crown exceeding 1 mm in one direction andor vertical depressibility Greater than 20 mm in both directions andor vertical depressibility
Examiner calibration
The data will be compared from indices or measurements taken by the examiner on three different patients at two different times within a 60-minute period to measure the intra-examiner accuracy and reproducibility
A minimum of three subjects are to be recruited to participate in the calibration The subjects should exhibit a range of the criteria being assessed in the index or measurements being performed ie subjects with moderate to severe periodontal disease
The examiner will score 3 teeth per subject within the same quadrant The examiner will measure each subject calling out the measurements site by site while the assistant records
Duplicate measurements of the subjects will be taken within 60 minutes following the initial measurements The assistant will record the second set of data
The examiner will not compare the two sets of data at any time during the calibration The examiner will not discuss their measurements with the assistant or the subject during the calibration
The assistant recording the data will be responsible for handling the data sheets The examiner will have no access to any of the data sheets during the course of the calibration
The data sets will be analyzed for percent agreement Acceptable percent agreement will reflect the limits set for the different parameters measured
Acceptable percent agreement will be 90 within 1mm for probing depth recession and attachment level and 70 within 0 mm
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?:
False
Is an FDA AA801 Violation?:
None