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

Evaluation of the Stability of Implants Placed in Low Quality Bone Following The Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial

the use of osseodensification technique compared to ridge expansion screws in low bone quality

Study Overview

• Status: Recruiting
• Conditions: Low Bone Density
• Intervention / Treatment: Procedure: Densah burs; Procedure: Ridge expansion screws

Detailed Description

using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam Samir, Assis. lect.; Phone Number: +201225113158; Email: mariam.bibawi@dentistry.cu.edu.eg
• Study Contact Backup: Name: Ahmed El Barbary, Assis. prof.; Email: ahmed.barbari@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Mariam Samir, master; Phone Number: +201225113158; Email: mariam.bibawi@dentistry.cu.edu.eg
    • Contact: Ahmed E Barbary; Email: ahmed.barbari@dentistry.cu.edu.eg
    • Principal Investigator: Mariam Samir, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osseodensification technique group; 10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs	Procedure: Densah burs; using Densah burs to prepare implant osteotomy
Active Comparator: Ridge expansion screw group; 10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws	Procedure: Ridge expansion screws; using Ridge expansion screws to prepare implant osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	assessing the stability using Osstell	change from baseline at 3 month
Implant stability	assessing the stability using Osstell	change from baseline at 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic bone density	using CBCT in mm	change from baseline at 3 month
Radiographic bone density	using CBCT in mm	change from baseline at 6 month
Change in crestal bone level	using CBCT in mm	change from baseline at 3 month
Change in crestal bone level	using CBCT in mm	change from baseline at 6 month
Change in buccolingual bone width	using CBCT in mm	change from baseline at 3 month
Change in buccolingual bone width	using CBCT in mm	change from baseline at 6 month
Patient reported outcomes	10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience	at time of surgery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed El Barbary, Assis. prof., Main supervisor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: osseodensification; ridge expansion screw
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 12722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

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