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OpenTrials
Completed

NCT Number: NCT06426719

Efficiency of Using Osseodensification Protocol

the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges?

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Key information

Conditions

Alveolar Bone Resorption

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Magdy Mostafa shehata

Cairo, 11799, Egypt

About this study

a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years old.
  • In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core.
  • Alveolar ridges with narrow crest and wider base.

Exclusion criteria

  • Uncontrolled diabetic patients
  • Heavy Smokers
  • Patients suffering from osteoporosis
  • Patients receiving chemo or radio therapy
  • Patients suffering from bleeding disorders
  • Patients suffering from intraosseous lesions at the proposed site of implant
  • Patients with insufficient alveolar bone hight less than 10 mm.
  • Resorbed ridge with a narrow base.

Treatment and study plan

Alveolar ridge wideninig via applying osseodensification protocol using densah burs

Procedure

alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion

Alveolar ridge widening via hand osteotomes

Procedure

Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion

Primary outcomes

  1. efficiency of ridge widening technique

    Time frame: intraoperative and within 3 days post operative

    the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT

Secondary outcomes

  1. primary stability of implant

    Time frame: intra-operative after dental implant placement

    the primary stability of the inserted dental implant is measured via osstell device

  2. length of surgical procedure

    Time frame: During surgery

    the time required for completion of the surgical procedure is measured in minutes using stop watch

  3. Value of pain

    Time frame: Immediate post operative

    the degree of pain or discomfort examined by the patient during the ridge widening procedure is recorded using a visual scale where 0 represents no pain while 1 minimum pain and 10 is maximum pain

Sponsors and collaborators

Lead sponsor

Mohamed Magdy Mostafa Shehata

Other

Collaborators

  • Cairo University

Registry information

Official study title

Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 23, 2024
Registry last updated
May 23, 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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