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Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial

Primary Purpose

Completely Edentulous Maxilla, Implant Placement, Maxillary Implant Overdenture

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
osteotomy for implant placement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Completely Edentulous Maxilla

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with completely edentulous maxilla.
  2. Sufficient inter-arch space not less 13mm inter-arch space.
  3. sufficient bone height to allow usage of at least 10mm implant length.
  4. Normal maxilla-mandibular relationship.
  5. minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter.
  6. participants more than forty years old.
  7. Opposing fully or partially restored dentition.

Exclusion Criteria:

  • 1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients.

    5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region

Sites / Locations

  • faculty of dentistry- Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional drilling group

osseodensification drilling group

Arm Description

drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.

bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.

Outcomes

Primary Outcome Measures

Peri-implant marginal bone loss
Radiographic follow up will be performed for marginal bone loss. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time of implant placement (base line) then at 4,12 months.

Secondary Outcome Measures

Implant stability measurements
The Osstell will be used according to the manufacturer's instructions and held perpendicular to the provided implant smart peg. Osstell values (ISQ) are going to be obtained for the bucco-lingual, mesio-distal surfaces of each implant. Three measurements will be made for each surface and the mean will be obtained for statistical analysis.for each implant will be done at the time of surgery, at 4 weeks , 7weeks and 4 months

Full Information

First Posted
September 26, 2022
Last Updated
September 28, 2022
Sponsor
Cairo University
Collaborators
prof. Nadia Ahmed Abbas, dr. Doaa Mahmoud abd elhameed elkady
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1. Study Identification

Unique Protocol Identification Number
NCT05559632
Brief Title
Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Official Title
Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
prof. Nadia Ahmed Abbas, dr. Doaa Mahmoud abd elhameed elkady

4. Oversight

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

5. Study Description

Brief Summary
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.
Detailed Description
Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis. medical and dental history A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used. The complete denture will be constructed following conventional denture fabrication procedures. CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement. A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer. Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion. Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction. All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse. After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. * Number of visits & follow up period 5 visits for construction of denture 1 visit for CBCT 1 visit for implant insertion 1 visit for attachment placement and pick-up of overdenture Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Completely Edentulous Maxilla, Implant Placement, Maxillary Implant Overdenture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional drilling group
Arm Type
Active Comparator
Arm Description
drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
Arm Title
osseodensification drilling group
Arm Type
Experimental
Arm Description
bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Intervention Type
Procedure
Intervention Name(s)
osteotomy for implant placement
Intervention Description
preparing the bone for implant placement
Primary Outcome Measure Information:
Title
Peri-implant marginal bone loss
Description
Radiographic follow up will be performed for marginal bone loss. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time of implant placement (base line) then at 4,12 months.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Implant stability measurements
Description
The Osstell will be used according to the manufacturer's instructions and held perpendicular to the provided implant smart peg. Osstell values (ISQ) are going to be obtained for the bucco-lingual, mesio-distal surfaces of each implant. Three measurements will be made for each surface and the mean will be obtained for statistical analysis.for each implant will be done at the time of surgery, at 4 weeks , 7weeks and 4 months
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with completely edentulous maxilla. Sufficient inter-arch space not less 13mm inter-arch space. sufficient bone height to allow usage of at least 10mm implant length. Normal maxilla-mandibular relationship. minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter. participants more than forty years old. Opposing fully or partially restored dentition. Exclusion Criteria: 1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients. 5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa essam mohamed
Phone
01158291633
Email
marwa.essam@dentistry.cu.edu.eg
Facility Information:
Facility Name
faculty of dentistry- Cairo university
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial

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