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

NCT05559632 | Unknown Phase 2 DMC

• 1 other identifier: 13722
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Completely Edentulous Maxilla; Implant Placement; Maxillary Implant Overdenture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Implant stability measurements

  4 months

Study Arms (2)

conventional drilling group

ACTIVE COMPARATOR

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

Procedure: osteotomy for implant placement

osseodensification drilling group

EXPERIMENTAL

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

Interventions

osteotomy for implant placement PROCEDURE

preparing the bone for implant placement

conventional drilling group; osseodensification drilling group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Cairo University: lead
• prof. Nadia Ahmed Abbas: collaborator
• dr. Doaa Mahmoud abd elhameed elkady: collaborator

Study Sites (1)

faculty of dentistry- Cairo university

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Interventions

Osteotomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Central Study Contacts

marwa essam mohamed

CONTACT

01158291633; marwa.essam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture assistant

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

EG (1)