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

Low Bone Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330546
• Other study ID #: 12722
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Mariam Samir, Assis. lect.
• Phone: +201225113158
• Email: mariam.bibawi[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Low Bone Density

Intervention

Procedure:
• Densah burs
using Densah burs to prepare implant osteotomy
• Ridge expansion screws
using Ridge expansion screws to prepare implant osteotomy

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability	assessing the stability using Osstell	change from baseline at 3 month
Primary	Implant stability	assessing the stability using Osstell	change from baseline at 6 month
Secondary	Radiographic bone density	using CBCT in mm	change from baseline at 3 month
Secondary	Radiographic bone density	using CBCT in mm	change from baseline at 6 month
Secondary	Change in crestal bone level	using CBCT in mm	change from baseline at 3 month
Secondary	Change in crestal bone level	using CBCT in mm	change from baseline at 6 month
Secondary	Change in buccolingual bone width	using CBCT in mm	change from baseline at 3 month
Secondary	Change in buccolingual bone width	using CBCT in mm	change from baseline at 6 month
Secondary	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