Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-07-28
Brief Title:
Clinical and Radiographic Evaluation of Three Different Modalities for Management of Distal Extension Atrophied Mandibular Ridge A One Year Prospective Study
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Three Different Modalities for Management of Distal Extension Atrophied Mandibular Ridge A One Year Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
Nine patients selected for this study with mandibular free end saddle and atrophied posterior ridge according to treatment options all patients will be divided randomly into 3 groups
Group A included three participants who will receive implant retained partial overdentures
Group B included three participants who will receive short implants supported fixed prosthesis
Group C included three participants who will receive long implant supported fixed prosthesis after ridge augmentation
For Group A Implant retained partial overdenture The implants will be inserted in first premolar areas and partial overdenture will be connected with implant by locator attachment
For Group B Short implant supported fixed prosthesis The implants will be inserted in first premolar second premolar and first molar areas without any ridge augmentation and the implant will be connected by fixed prosthesis
For group C Long implant supported fixed prosthesis after ridge augmentation The implants will be inserted in first premolar second premolar and first molar areas with ridge augmentation by using Khoury technique17 and the implants will be connected by fixed prosthesis
Clinical evaluation will be made in terms of
Gingival Index GI
Plaque Index PI
Pocket Depth PD
Width of Keratinized Mucosa KM
Implant Stability ISQ
Radiographic evaluation will include mandibular residual ridge resorption using the proportional area measurements
evaluation periods will be performed at time of insertion T0 6 months after insertion T6 12 months after insertion T6
Group A included three participants who will receive implant retained partial overdentures
Group B included three participants who will receive short implants supported fixed prosthesis
Group C included three participants who will receive long implant supported fixed prosthesis after ridge augmentation
For Group A Implant retained partial overdenture The implants will be inserted in first premolar areas and partial overdenture will be connected with implant by locator attachment
For Group B Short implant supported fixed prosthesis The implants will be inserted in first premolar second premolar and first molar areas without any ridge augmentation and the implant will be connected by fixed prosthesis
For group C Long implant supported fixed prosthesis after ridge augmentation The implants will be inserted in first premolar second premolar and first molar areas with ridge augmentation by using Khoury technique17 and the implants will be connected by fixed prosthesis
Clinical evaluation will be made in terms of
Gingival Index GI
Plaque Index PI
Pocket Depth PD
Width of Keratinized Mucosa KM
Implant Stability ISQ
Radiographic evaluation will include mandibular residual ridge resorption using the proportional area measurements
evaluation periods will be performed at time of insertion T0 6 months after insertion T6 12 months after insertion T6
Detailed Description:
Introduction Long span distal-extension removable partial dentures RPDs are associated with several problems related to their stability retention esthetics and masticatory efficiency12 The lack of distal dental support in mandibular Kennedy class I distal extension-RPDs results in transmission of vertical horizontal and torsional forces to supporting tissues during mastication with subsequent adverse changes in both abutment teeth and edentulous areas In addition constant pressure from the denture base gradually causes ridge resorption under the denture base3-5 Prosthodontic management of long span distal extension partially edentulous patients has expanded with the introduction of Osseo integrated implants6 The use of implants to support and retain distal extension partial overdentures has been reported to minimize RPD dislodgement provide additional retention and stability prevent the development of combination syndrome and improve patient satisfaction in a cost-effective manner78 Moreover placing bilateral dental implants distal to canine area of the residual alveolar ridges is becoming a popular treatment choice in case of limited height of posterior mandibular ridge7910 Such prostheses can be retained to the implants with different unsplinted anchors such as ball Locator and magnetic attachments1 Although Implant-supported distal extension prosthesis could be an ideal treatment option alveolar resorption lack of sufficient bone volume and proximity to the inferior alveolar nerve presenting a difficult clinical situation for positioning endosseous implants A bone height of 10-12mm is generally considered to be the minimal amount of bone required to place implants of sufficient length 9-11mm long which are most likely to generate good long-term results and to minimize the risk of permanent damage to the alveolar inferior nerve11 Often times however the amount of residual bone above the mandibular canal is 10mm and implant placement is considered at a higher risk of failure11To address a case of reduced bone height in the posterior mandible either ridge augmentation or placement of short implant could be the proposed approaches
The development of bone augmentation procedures has allowed placement of dental implants into jawbone areas lacking an amount of bone sufficient for standard implant placement11 While augmentation procedures can yield favorable outcomes they can be associated with significant postoperative morbidity and complications12 On the other hand short implants could be a simpler cheaper and faster alternative to augmentation procedures even if in some critical cases the residual bone crest above the inferior alveolar nerve is only 5-7 mm in height and therefore the surgical augmentation treatment is mandatory1112 However it is commonly perceived that short implants do not have a good long-term prognosis when compared with longer implants Although preliminary findings suggest that short implants may be a better alternative to various bone augmentation procedures long-term follow-up evaluations are indicated to draw definitive conclusion13-15 Implant-supported removable prostheses improve patients satisfaction with treatment and quality of life When canines are the only present abutments insertion of the implants distal the canine areas can provide support and retention eliminate the use of unesthetic retentive clasps and prevent unfavorable horizontal forces that may damage the abutment periodontium However some biological and mechanical complications remain Mechanical complications associated with implant-supported overdentures are loss of retention of attachment systems the need to replace retention elements and to reline or repair the resin portion of the denture and implant fracture Despite their success implant-supported removable prostheses require periodic maintenance
Based on the proceeding three treatment modalities could be the solution for long span distal-extension removable partial dentures RPDs implant retained partial overdenture short implant supported fixed prosthesis and long implant supported fixed prosthesis after ridge augmentation Comparing the clinical and radiographic outcomes of the three different treatment modalities are relatively scarce in literature to explore which treatment is more appropriate regarding periodontal tissue health and patient satisfaction
Aim of the work This study will aim to assess the clinical and radiographic outcomes of three different treatments modalities for management of distal extension atrophied mandibular ridge A implant retained partial overdenture B short implant supported fixed prosthesis C long implant supported prosthesis after ridge augmentation
Clinical evaluation will be made in terms of
Gingival Index GI
Plaque Index PI
Pocket Depth PD
Width of Keratinized Mucosa KM
Implant Stability ISQ
Radiographic evaluation will include mandibular residual ridge resorption using the proportional area measurements
Materials and Methods
1 Patient selection and grouping
Nine patients aged between 45 to 70 years will be selected from outpatient clinic of the Removable Prosthodontic Department Faculty of Dentistry Mansoura University Egypt
All selected participants will be required to have the following inclusion criteria
1 Atrophied partially edentulism in the posterior mandible having a residual bone height of 6-8mm bone between inferior alveolar nerve and crest of the ridge to receive implants 2 Residual alveolar ridges covered with healthy mucosa without any signs of inflammation or remaining roots
3 Normal maxilla-mandibular relationship with sufficient available restorative space16
Patients with the following conditions will be excluded
1 Diseases that affect bone metabolism eg uncontrolled diabetes hyperparathyroidism and osteoporosis
2 Systemic diseases that may affect osteointegration or complicate surgical procedures eg liver diseases heart diseases and radiotherapy in head and neck region
3 Abnormal or harmful habits eg smoking bruxism and clenching
4 Uncooperative patients and patients with poor oral hygiene
The study protocol will be reviewed and approved by ethical committee of the Faculty of Dentistry Mansoura University
Detailed written information about treatment strategy will be provided to all participants who meet the criteria and then they will sign an informed consent After consent will be given eligible participants will be randomly divided into three groups
1 Group A included three participants who will receive implant retained partial overdentures 2 Group B included three participants who will receive short implants supported fixed prosthesis 3 Group C included three participants who will receive long implant supported fixed prosthesis after ridge augmentation
2 Surgical and prosthetic procedures
Cone Beam Computed Tomography CBCT will be performed for each patient to mark implant placement sites detect magnification errors and select proper implant lengths The implants will be inserted using non-submerged flapless surgical approach with the same operator in all groups
For Group A Implant retained partial overdenture The implants will be inserted in first premolar areas and partial overdenture will be connected with implant by locator attachment
For Group B Short implant supported fixed prosthesis The implants will be inserted in first premolar second premolar and first molar areas without any ridge augmentation and the implant will be connected by fixed prosthesis
For group C Long implant supported fixed prosthesis after ridge augmentation The implants will be inserted in first premolar second premolar and first molar areas with ridge augmentation by using Khoury technique17 and the implants will be connected by fixed prosthesis
3 Evaluation of peri-implant tissues Clinical and radiographic evaluations of peri-implant tissues will be performed after definite prosthesis insertion T0 six T6 and twelve T12 months after insertion
A Clinical evaluation
The parameters for clinical evaluation of peri-implant tissue included plaque index gingival index pocket depth thickness of keratinized mucosa and implant stability
1 Gingival index GI
Modified gingival index will be recorded according to Mombelli et al18 as follows score 0 normal gingival score 1 mild inflammation slight change in color slight edema but no bleeding on probing score 2 moderate inflammation redness edema and bleeding on probing and score 3 sever inflammation marked redness edema ulceration with tendency to spontaneous bleeding
2 Plaque index PI
Plaque will be assessed according to modified plaque index describe by Mombelli et al18 as follows score 0 no plaque detected score 1 plaque recognized only by running a probe across a smooth marginal surface of the implant score 2 plaque can be seen by naked eye and score 3 abundance of soft mater
3 Pocket depth PD
Using a calibrated plastic periodontal probe the distance between marginal border of the gingiva and the tip of the probe will be measured in mm and considered as pocket depth PD19
4 The width of keratinized mucosa KM
The width of peri-implant keratinized mucosa will be measured in mm using a calibrated plastic periodontal probe Differences in color texture and mobility between the keratinized mucosa and the lining mucosa served as markers for the detection of the muco-gingival junction20 KM was then measured as the distance between the gingival margin and the muco-gingival junction
5 Implant stability ISQ
Implant stability will be assessed using resonance frequency analysis RFA The resonance frequencies will be measured with the osstell device implant stability meter and expressed with ISQ measurement scale implant stability quotient 2122
B Radiographic evaluation
Radiographic evaluation will be assessed using Cone Beam Computed Tomography CBCT and periapical radiographic X ray
Implant dimensions in the radiographs will be compared with actual implant dimensions to detect magnification errors The ratio between implant dimensions in the radiographs and actual implant dimensions will be used to modify the apparent measurement of peri-implant bone levels in the radiographs to obtain their actual values
Crestal alveolar bone changes will be determined along vertical and horizontal planes as recommended by Elsyad et al 1923
For vertical alveolar bone changes the distance between implant shoulder A point and first bone to implant contact B point called DIB indicates vertical bone level in mm AB line
For horizontal alveolar bone changes the distance between the marginal bone level C point which represents the intersection point of a tangent to the horizontal bone crest CD line and another tangent to the crater-shaped defect CB line and the implant perpendicularly indicates horizontal bone levelmm
Vertical bone loss VBL will be calculated by subtracting DIB at T6 and T12 from DIB at T0 Horizontal bone loss HBLO will be calculated by subtracting HBL at T6 and T12 from HBL at T0
Crestal alveolar bone changes vertical and horizontal bone loss will be measured at mesial and distal surface of each implant
C Implant survival To estimate the cumulative survival rate a Kaplan-Meier analysis will be used involving the following clinical parameters for success suggested by Albrektsson and Isidor 24 no clinical problems pus suppuration implant mobility and pain and limited change in peri-implant crestal bone level as assessed by radiographic follow-up during the first year of loading 15 mm and annual additional bone loss thereafter 02 mmyear An implant was classified as a survived implant when it was still functioning irrespective of its conditions and do not need immediate removal but did not fulfill the success criteria
The development of bone augmentation procedures has allowed placement of dental implants into jawbone areas lacking an amount of bone sufficient for standard implant placement11 While augmentation procedures can yield favorable outcomes they can be associated with significant postoperative morbidity and complications12 On the other hand short implants could be a simpler cheaper and faster alternative to augmentation procedures even if in some critical cases the residual bone crest above the inferior alveolar nerve is only 5-7 mm in height and therefore the surgical augmentation treatment is mandatory1112 However it is commonly perceived that short implants do not have a good long-term prognosis when compared with longer implants Although preliminary findings suggest that short implants may be a better alternative to various bone augmentation procedures long-term follow-up evaluations are indicated to draw definitive conclusion13-15 Implant-supported removable prostheses improve patients satisfaction with treatment and quality of life When canines are the only present abutments insertion of the implants distal the canine areas can provide support and retention eliminate the use of unesthetic retentive clasps and prevent unfavorable horizontal forces that may damage the abutment periodontium However some biological and mechanical complications remain Mechanical complications associated with implant-supported overdentures are loss of retention of attachment systems the need to replace retention elements and to reline or repair the resin portion of the denture and implant fracture Despite their success implant-supported removable prostheses require periodic maintenance
Based on the proceeding three treatment modalities could be the solution for long span distal-extension removable partial dentures RPDs implant retained partial overdenture short implant supported fixed prosthesis and long implant supported fixed prosthesis after ridge augmentation Comparing the clinical and radiographic outcomes of the three different treatment modalities are relatively scarce in literature to explore which treatment is more appropriate regarding periodontal tissue health and patient satisfaction
Aim of the work This study will aim to assess the clinical and radiographic outcomes of three different treatments modalities for management of distal extension atrophied mandibular ridge A implant retained partial overdenture B short implant supported fixed prosthesis C long implant supported prosthesis after ridge augmentation
Clinical evaluation will be made in terms of
Gingival Index GI
Plaque Index PI
Pocket Depth PD
Width of Keratinized Mucosa KM
Implant Stability ISQ
Radiographic evaluation will include mandibular residual ridge resorption using the proportional area measurements
Materials and Methods
1 Patient selection and grouping
Nine patients aged between 45 to 70 years will be selected from outpatient clinic of the Removable Prosthodontic Department Faculty of Dentistry Mansoura University Egypt
All selected participants will be required to have the following inclusion criteria
1 Atrophied partially edentulism in the posterior mandible having a residual bone height of 6-8mm bone between inferior alveolar nerve and crest of the ridge to receive implants 2 Residual alveolar ridges covered with healthy mucosa without any signs of inflammation or remaining roots
3 Normal maxilla-mandibular relationship with sufficient available restorative space16
Patients with the following conditions will be excluded
1 Diseases that affect bone metabolism eg uncontrolled diabetes hyperparathyroidism and osteoporosis
2 Systemic diseases that may affect osteointegration or complicate surgical procedures eg liver diseases heart diseases and radiotherapy in head and neck region
3 Abnormal or harmful habits eg smoking bruxism and clenching
4 Uncooperative patients and patients with poor oral hygiene
The study protocol will be reviewed and approved by ethical committee of the Faculty of Dentistry Mansoura University
Detailed written information about treatment strategy will be provided to all participants who meet the criteria and then they will sign an informed consent After consent will be given eligible participants will be randomly divided into three groups
1 Group A included three participants who will receive implant retained partial overdentures 2 Group B included three participants who will receive short implants supported fixed prosthesis 3 Group C included three participants who will receive long implant supported fixed prosthesis after ridge augmentation
2 Surgical and prosthetic procedures
Cone Beam Computed Tomography CBCT will be performed for each patient to mark implant placement sites detect magnification errors and select proper implant lengths The implants will be inserted using non-submerged flapless surgical approach with the same operator in all groups
For Group A Implant retained partial overdenture The implants will be inserted in first premolar areas and partial overdenture will be connected with implant by locator attachment
For Group B Short implant supported fixed prosthesis The implants will be inserted in first premolar second premolar and first molar areas without any ridge augmentation and the implant will be connected by fixed prosthesis
For group C Long implant supported fixed prosthesis after ridge augmentation The implants will be inserted in first premolar second premolar and first molar areas with ridge augmentation by using Khoury technique17 and the implants will be connected by fixed prosthesis
3 Evaluation of peri-implant tissues Clinical and radiographic evaluations of peri-implant tissues will be performed after definite prosthesis insertion T0 six T6 and twelve T12 months after insertion
A Clinical evaluation
The parameters for clinical evaluation of peri-implant tissue included plaque index gingival index pocket depth thickness of keratinized mucosa and implant stability
1 Gingival index GI
Modified gingival index will be recorded according to Mombelli et al18 as follows score 0 normal gingival score 1 mild inflammation slight change in color slight edema but no bleeding on probing score 2 moderate inflammation redness edema and bleeding on probing and score 3 sever inflammation marked redness edema ulceration with tendency to spontaneous bleeding
2 Plaque index PI
Plaque will be assessed according to modified plaque index describe by Mombelli et al18 as follows score 0 no plaque detected score 1 plaque recognized only by running a probe across a smooth marginal surface of the implant score 2 plaque can be seen by naked eye and score 3 abundance of soft mater
3 Pocket depth PD
Using a calibrated plastic periodontal probe the distance between marginal border of the gingiva and the tip of the probe will be measured in mm and considered as pocket depth PD19
4 The width of keratinized mucosa KM
The width of peri-implant keratinized mucosa will be measured in mm using a calibrated plastic periodontal probe Differences in color texture and mobility between the keratinized mucosa and the lining mucosa served as markers for the detection of the muco-gingival junction20 KM was then measured as the distance between the gingival margin and the muco-gingival junction
5 Implant stability ISQ
Implant stability will be assessed using resonance frequency analysis RFA The resonance frequencies will be measured with the osstell device implant stability meter and expressed with ISQ measurement scale implant stability quotient 2122
B Radiographic evaluation
Radiographic evaluation will be assessed using Cone Beam Computed Tomography CBCT and periapical radiographic X ray
Implant dimensions in the radiographs will be compared with actual implant dimensions to detect magnification errors The ratio between implant dimensions in the radiographs and actual implant dimensions will be used to modify the apparent measurement of peri-implant bone levels in the radiographs to obtain their actual values
Crestal alveolar bone changes will be determined along vertical and horizontal planes as recommended by Elsyad et al 1923
For vertical alveolar bone changes the distance between implant shoulder A point and first bone to implant contact B point called DIB indicates vertical bone level in mm AB line
For horizontal alveolar bone changes the distance between the marginal bone level C point which represents the intersection point of a tangent to the horizontal bone crest CD line and another tangent to the crater-shaped defect CB line and the implant perpendicularly indicates horizontal bone levelmm
Vertical bone loss VBL will be calculated by subtracting DIB at T6 and T12 from DIB at T0 Horizontal bone loss HBLO will be calculated by subtracting HBL at T6 and T12 from HBL at T0
Crestal alveolar bone changes vertical and horizontal bone loss will be measured at mesial and distal surface of each implant
C Implant survival To estimate the cumulative survival rate a Kaplan-Meier analysis will be used involving the following clinical parameters for success suggested by Albrektsson and Isidor 24 no clinical problems pus suppuration implant mobility and pain and limited change in peri-implant crestal bone level as assessed by radiographic follow-up during the first year of loading 15 mm and annual additional bone loss thereafter 02 mmyear An implant was classified as a survived implant when it was still functioning irrespective of its conditions and do not need immediate removal but did not fulfill the success criteria
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