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Evaluation of Implant Stability in Low Quality Bone Following The Use of Osseodensifiers Versus Ridge Expanders

Primary Purpose

Low Bone Density

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Densah burs
Ridge expansion screws
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Bone Density focused on measuring osseodensification, ridge expansion screw

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).

    • A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019).

      • The recipient site of the implant should be free from any pathological conditions.
      • No diagnosed bone disease or medication known to affect bone metabolism.
      • Patients who are cooperative, motivated and hygiene conscious.
      • Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017)

Exclusion Criteria:

  • Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).

    • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020).
    • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020).
    • Alcohol or drug abuse (Ibrahim et al., 2020).
    • Pregnant and lactating women.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osseodensification technique group

Ridge expansion screw group

Arm Description

10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs

10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws

Outcomes

Primary Outcome Measures

Implant stability
assessing the stability using Osstell
Implant stability
assessing the stability using Osstell

Secondary Outcome Measures

Radiographic bone density
using CBCT in mm
Radiographic bone density
using CBCT in mm
Change in crestal bone level
using CBCT in mm
Change in crestal bone level
using CBCT in mm
Change in buccolingual bone width
using CBCT in mm
Change in buccolingual bone width
using CBCT in mm
Patient reported outcomes
10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience

Full Information

First Posted
April 2, 2022
Last Updated
September 17, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05330546
Brief Title
Evaluation of Implant Stability in Low Quality Bone Following The Use of Osseodensifiers Versus Ridge Expanders
Official Title
Evaluation of the Stability of Implants Placed in Low Quality Bone Following The Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the use of osseodensification technique compared to ridge expansion screws in low bone quality
Detailed Description
using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Bone Density
Keywords
osseodensification, ridge expansion screw

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osseodensification technique group
Arm Type
Experimental
Arm Description
10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs
Arm Title
Ridge expansion screw group
Arm Type
Active Comparator
Arm Description
10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws
Intervention Type
Procedure
Intervention Name(s)
Densah burs
Intervention Description
using Densah burs to prepare implant osteotomy
Intervention Type
Procedure
Intervention Name(s)
Ridge expansion screws
Intervention Description
using Ridge expansion screws to prepare implant osteotomy
Primary Outcome Measure Information:
Title
Implant stability
Description
assessing the stability using Osstell
Time Frame
change from baseline at 3 month
Title
Implant stability
Description
assessing the stability using Osstell
Time Frame
change from baseline at 6 month
Secondary Outcome Measure Information:
Title
Radiographic bone density
Description
using CBCT in mm
Time Frame
change from baseline at 3 month
Title
Radiographic bone density
Description
using CBCT in mm
Time Frame
change from baseline at 6 month
Title
Change in crestal bone level
Description
using CBCT in mm
Time Frame
change from baseline at 3 month
Title
Change in crestal bone level
Description
using CBCT in mm
Time Frame
change from baseline at 6 month
Title
Change in buccolingual bone width
Description
using CBCT in mm
Time Frame
change from baseline at 3 month
Title
Change in buccolingual bone width
Description
using CBCT in mm
Time Frame
change from baseline at 6 month
Title
Patient reported outcomes
Description
10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience
Time Frame
at time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020). A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019). The recipient site of the implant should be free from any pathological conditions. No diagnosed bone disease or medication known to affect bone metabolism. Patients who are cooperative, motivated and hygiene conscious. Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017) Exclusion Criteria: Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021). Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020). Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020). Alcohol or drug abuse (Ibrahim et al., 2020). Pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Samir, Assis. lect.
Phone
+201225113158
Email
mariam.bibawi@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed El Barbary, Assis. prof.
Email
ahmed.barbari@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El Barbary, Assis. prof.
Organizational Affiliation
Main supervisor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Samir, master
Phone
+201225113158
Email
mariam.bibawi@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed E Barbary
Email
ahmed.barbari@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mariam Samir, Master

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
raw data will be shared upon request
IPD Sharing Time Frame
upon request for 2 days
IPD Sharing Access Criteria
file including the raw data

Learn more about this trial

Evaluation of Implant Stability in Low Quality Bone Following The Use of Osseodensifiers Versus Ridge Expanders

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