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Completed

NCT Number: NCT06770231

Peri-implant Bone Behaviour Using Two Drilling Techniques in Posterior Maxilla

Two different drilling techniques in posterior maxilla immediate loading implant

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Key information

Conditions

Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 12345, Egypt

About this study

One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.

On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with missing single or multiple teeth in posterior maxilla.
  • Age more than 18 years.
  • 10 mm or more vertical bone height is present.
  • Good oral hygiene.
  • Patients willing to be present during the study follow up intervals.
  • Patients free from any systemic diseases.
  • 6 mm or more ridge width is present.
  • Crown height space of at least 8 mm.
  • Patients without any para-functional habits (bruxism and clenching).

Exclusion criteria

  • Patients with any pathological lesion or root tips at the planned surgical site.
  • Patients with inadequate bone height and thickness.
  • Smoking more than 14 cigarettes per day.14
  • Alcohol or drug abuse.
  • Patients with systemic diseases that absolutely contraindicate implant placement.

Treatment and study plan

Single drill system

Other

New system for drilling

Primary outcomes

  1. Implant stability

    Time frame: 12 months

    Implant stability will be assessed at the time of implant insertion and at 3, 6 and 12 months after surgery.

  2. Modified Sulcus Bleeding Index (mBI)

    Time frame: 12 months

    It will be measured at 3,6 and 12 months post-operatively. Clinical signs and symptoms of inflammation of peri-implant mucosa will be graded using criteria of modified sulcus bleeding index (mBI).

  3. Peri-implant probing depth

    Time frame: 12 months

    Depth of the peri-implant sulcus will be recorded initially at the time of loading, 3, 6 and 12 months following implant loading by a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue

  4. Marginal Bone Loss

    Time frame: 12 months

    For the calculation of marginal bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional and panoramic long axis in the center of the implant and bisecting it

  5. Bone Density Recordings

    Time frame: 12 months

    Relative bone density records will be collected from the bucco-palatal view of the cross-sectional plane using the greyscale bone measuring tool

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

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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