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

Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.

Study Overview

• Status: Recruiting
• Conditions: Completely Edentulous Maxilla; Implant Placement; Maxillary Implant Overdenture
• Intervention / Treatment: Procedure: osteotomy for implant placement

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: marwa essam mohamed; Phone Number: 01158291633; Email: marwa.essam@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Faculty of Dentistry- Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional drilling group; drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.	Procedure: osteotomy for implant placement; preparing the bone for implant placement
Experimental: osseodensification drilling group; 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.	Procedure: osteotomy for implant placement; preparing the bone for implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: prof. Nadia Ahmed Abbas; dr. Doaa Mahmoud abd elhameed elkady

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 13722

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No