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

NCT ID: NCT05559632

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-11-30

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

Conditions

Completely Edentulous Maxilla; Implant Placement; Maxillary Implant Overdenture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

conventional drilling group

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

Group Type: ACTIVE_COMPARATOR

osteotomy for implant placement

Intervention Type: PROCEDURE

preparing the bone for implant placement

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.

Group Type: EXPERIMENTAL

osteotomy for implant placement

Intervention Type: PROCEDURE

preparing the bone for implant placement

Interventions

osteotomy for implant placement

preparing the bone for implant placement

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

prof. Nadia Ahmed Abbas

UNKNOWN

Sponsor Role: collaborator

dr. Doaa Mahmoud abd elhameed elkady

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Essam El-Dein Mohamed

lecture assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of dentistry- Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

marwa essam mohamed

Role: CONTACT

marwa.essam@dentistry.cu.edu.eg

01158291633

Other Identifiers

13722

Identifier Type: -

Identifier Source: org_study_id