Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT07108361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement: A Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Also, the alveolar ridge undergoes various remodeling processes following tooth extraction, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation. Immediate implant placement help preserve the alveolar ridge dimensions and buccal ridge contour. While osseodensification has shown promise in enhancing primary stability and bone microarchitecture, its clinical and microstructural effects in molar extraction sockets remain underexplored. Although there is ample documentation of information on the temperature that is generated during preparation of implant sites, there are no studies available in the literature comparing conventional drilling and osseodensification techniques; therefore, the present investigation was aimed at analyzing the efficacy of osseodensification compared to conventional drilling in terms of bone dimensions preservation , changes in bone architecture during implant site preparation and heat generation to define which technique can be safely applied to achieve the necessary implant primary stability without damaging the surrounding bone.
Aim of the study:
Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation
Aim of the study:
Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation
Detailed Description:
The proposed study consists of two arms: 1- Clinical arm, 2- Ex-Vivo arm
The clinical arm:
80 patients with hopeless teeth requiring extraction in the molar region and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain shams university according to the inclusion criteria. They will be randomly allocated into two equal groups. 40 patients in the osseodensification group and 40 patients in the conventional drilling group. Each group will be further subdivided into two groups with and without jumping gap graftingPerioperative and postoperative CBCT will be ordered, and perioperative and postoperative impressions will be made and scanned for each patient to prepare a virtual 3D model before extraction and after extraction and implant placement. Molar septum dimensions will be compared before and after implant placement in addition to evaluation of vertical and horizontal alveolar bone changes and changes in bone density after placement of immediate implant in extraction socket, also a volumetric analysis will be made to assess the changes in the buccal ridge contour before and after implant placement with and without grafting of the jumping gap. Clinical outcomes will be assessed including (success and survival of implants, insertion torque, ISQ values, Probing depth, modified pink esthetic score, KTW, and patient satisfaction) all the outcomes will be assessed as baseline before the implant placement and will be followed up at 0,6 and 12 months after implant placementThe Ex-Vivo arm: study will be conducted in an ex vivo animal model using porcine bones. The animals won't be used exclusively for this study and the bones will be collected as if it was disposable as waste material, so ethical approval will not be necessary. Both tibias of a single skeletally mature porcine will be collected on the day of the slaughter. To prepare the samples, approximately 15 mm of the articular surface and subchondral bone will be removed by transversely sectioning the bones, thereby exposing the medullary portion. Three canals for thermocouples at three different depths (2 mm: T1-cortical bone, 7.5 mm: T2-cancellous bone, and 10.5 mm: T3- deep cancellous bone) from the crest of the pig bone will be drilled using 1.5 mm twist drill perpendicularly to each implant site preparation and using intermittent cutting to a distance approximately 1 mm from the planned osteotomy site.The thermocouples will be secured to the bone blocks at a distance of approximately 1 mm from the future osteotomy and insulated using sticky wax at the canal opening This study will be performed on 12 samples removed from the tibias, divided into two groups according to the drilling technique: a control group of the conventional technique (CT) (n=6), and a test group of osseodensification (OD) (n=6). The evaluation of bone microstructure using Micro-CT will follow the guidelines proposed by Bouxsein et al. (2010), which includes the use of terminologies, procedures, images, and reporting of the results. The thermocouples will be connected to a digital thermometer that allows continuous temperature reading, and temperature changes (baseline and final temperature readings) during the osteotomy preparation will be recorded for statistical analysis
The clinical arm:
80 patients with hopeless teeth requiring extraction in the molar region and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain shams university according to the inclusion criteria. They will be randomly allocated into two equal groups. 40 patients in the osseodensification group and 40 patients in the conventional drilling group. Each group will be further subdivided into two groups with and without jumping gap graftingPerioperative and postoperative CBCT will be ordered, and perioperative and postoperative impressions will be made and scanned for each patient to prepare a virtual 3D model before extraction and after extraction and implant placement. Molar septum dimensions will be compared before and after implant placement in addition to evaluation of vertical and horizontal alveolar bone changes and changes in bone density after placement of immediate implant in extraction socket, also a volumetric analysis will be made to assess the changes in the buccal ridge contour before and after implant placement with and without grafting of the jumping gap. Clinical outcomes will be assessed including (success and survival of implants, insertion torque, ISQ values, Probing depth, modified pink esthetic score, KTW, and patient satisfaction) all the outcomes will be assessed as baseline before the implant placement and will be followed up at 0,6 and 12 months after implant placementThe Ex-Vivo arm: study will be conducted in an ex vivo animal model using porcine bones. The animals won't be used exclusively for this study and the bones will be collected as if it was disposable as waste material, so ethical approval will not be necessary. Both tibias of a single skeletally mature porcine will be collected on the day of the slaughter. To prepare the samples, approximately 15 mm of the articular surface and subchondral bone will be removed by transversely sectioning the bones, thereby exposing the medullary portion. Three canals for thermocouples at three different depths (2 mm: T1-cortical bone, 7.5 mm: T2-cancellous bone, and 10.5 mm: T3- deep cancellous bone) from the crest of the pig bone will be drilled using 1.5 mm twist drill perpendicularly to each implant site preparation and using intermittent cutting to a distance approximately 1 mm from the planned osteotomy site.The thermocouples will be secured to the bone blocks at a distance of approximately 1 mm from the future osteotomy and insulated using sticky wax at the canal opening This study will be performed on 12 samples removed from the tibias, divided into two groups according to the drilling technique: a control group of the conventional technique (CT) (n=6), and a test group of osseodensification (OD) (n=6). The evaluation of bone microstructure using Micro-CT will follow the guidelines proposed by Bouxsein et al. (2010), which includes the use of terminologies, procedures, images, and reporting of the results. The thermocouples will be connected to a digital thermometer that allows continuous temperature reading, and temperature changes (baseline and final temperature readings) during the osteotomy preparation will be recorded for statistical analysis
Study Oversight
Has Oversight DMC:
False
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?: