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NCT Number: NCT06519383

Comparison Of Implant Position Achieved With Fully Guided Versus Partially Guided Implant Placement

Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a prerequisite for an optimal outcome.Computer assisted implant surgery maybe beneficial in patients with limited bone and proximity to anatomic structures.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth.As a result, the focus in contemporary implant dentistry has shifted towards the optimization of treatment concepts with aesthetics and function as an important outcome parameter.In this respect, implant installation should be prosthetically -driven, at the same time taking into account anatomical limitations as well as restrictions in terms of bone availability. Apart from aesthetics, a correct implant position may reduce biological and technical complications, favourable esthetic and prosthetic outcome, long term stability of peri-implant tissues, optimal occlusal contacts and implant loading. One possible tool that may facilitate a more accurate implant positioning is guided implant surgery.Virtual implant planning facilitates desired inter implant distance and depth. A top down planning wherein digital images of the edentulous area and mock wax up of the prosthesis is superimposed, allows precise implant placement planning. This digital planning can be converted into a surgical/virtual guide via a 3D printer or a milling machine.Fully guided surgery is based on a surgical guide which will assist the clinician in every step of the surgery starting from the first drill to the implant placement through the use of guiding sleeves in the guide. A partially-guided protocol differs only in the final step: after guided preparation of the osteotomy, the guide is removed and the implant is installed free-handedly.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients in need of replacement of missing teeth.
  • Mouth opening at least 30 mm.
  • Age>18 years.
  • Limited vertical or horizontal dimension of the alveolar ridge.
  • Unfavorable bone morphology necessitating correct implant position.
  • When minimally invasive (e.g. flapless) surgery is intended.
  • When immediate implant restoration is planned.

Exclusion criteria

  • Heavy smokers (more than 10 cigarettes per day)
  • Uncontrolled diabetes
  • Metabolic bone disorders
  • History of radiotherapy of the head and neck
  • Recent chemotherapy
  • Use of drugs influencing bone or soft tissue healing (e.g., high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
  • Pregnant and/or lactating women

Treatment and study plan

guided implant surgery

Procedure

Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.

Primary outcomes

  1. Accuracy of implant position

    Time frame: 2 weeks

    3D deviation of planned implant position to final implant position

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Prabhuji MLV, MDS

CONTACT

[email protected]

9448057407 ext. 91

Dr. Supriya K Hombal, MDS

CONTACT

[email protected]

9113088652 ext. 91

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Comparative Evaluation Of Accuracy Of Implant Position Achieved With Static Computer Assisted Fully Guided Implant Placement (sCAIP) And Conventional Cast Based Partially Guided Implant Placement (cPGIP)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 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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