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Completed

NCT Number: NCT05330546

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Densah burs

Procedure

using Densah burs to prepare implant osteotomy

Ridge expansion screws

Procedure

using Ridge expansion screws to prepare implant osteotomy

Primary outcomes

  1. Implant stability

    Time frame: change from baseline at 3 month

    assessing the stability using Osstell

  2. Implant stability

    Time frame: change from baseline at 6 month

    assessing the stability using Osstell

Secondary outcomes

  1. Radiographic bone density

    Time frame: change from baseline at 3 month

    using CBCT in mm

  2. Radiographic bone density

    Time frame: change from baseline at 6 month

    using CBCT in mm

  3. Change in crestal bone level

    Time frame: change from baseline at 3 month

    using CBCT in mm

  4. Change in crestal bone level

    Time frame: change from baseline at 6 month

    using CBCT in mm

  5. Change in buccolingual bone width

    Time frame: change from baseline at 3 month

    using CBCT in mm

  6. Change in buccolingual bone width

    Time frame: change from baseline at 6 month

    using CBCT in mm

  7. Patient reported outcomes

    Time frame: at time of surgery

    10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2022
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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