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Completed

NCT Number: NCT05295082

Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement

This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AinShams University

Cairo, Egypt

About this study

This study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.

the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (CBCT ) will be performed to compare the virtual implant position and the actual implant position.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Single missing maxillary premolar or molar tooth.
  • Both genders aged from 20-50 years.
  • Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire. (Pendleton et al,.2004)
  • Mesio-distal space ≥ 7 mm.
  • Bone width in bucco-lingual direction ≥ 6 mm.
  • Uniform alveolar ridge with no undercuts.
  • Present mesial and distal sound neighboring teeth.
  • At least 4 natural remaining teeth on the same arch.
  • Mouth opening at least 30 mm.

Exclusion criteria

  • Pregnant and lactating females. 2) Smokers. 3) Poor oral hygiene. 4) Vulnerable groups of patients' e.g. (handicapped patients).

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Treatment and study plan

guided trephination-based drilling protocol

Procedure

the implant site preparation in this group will be done by guided trephination protocol which uses the surgical guide to trephine the implant site then remove the guide and continue the drilling in a freehand manner

guided Conventional drilling-based protocol

Procedure

the implant site preparation in this group will be done by a guided conventional drilling protocol which uses the surgical guide to guide the sequential drills up to the final drill

Primary outcomes

  1. Horizontal deviation at apex of the implant.

    Time frame: immediately after the intervention

    measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position

  2. •Horizontal deviation at implant shoulder.

    Time frame: immediately after the intervention

    measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position

  3. Angular deviation.

    Time frame: immediately after the intervention

    measure the Angular deviation of the implant between the virtual planning position and the actual implant position

Secondary outcomes

  1. The duration of the surgery

    Time frame: during the surgery

    measure the time of the surgery from the first drill to the implant placement

  2. Satisfaction assessed by the Visual Analogue Scale

    Time frame: immediately after the intervention

    measure the patient satisfaction score on terms of pain and discomfort from 1 to 10

Sponsors and collaborators

Lead sponsor

Mohammed Ramadan

Other

Registry information

Official study title

Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 24, 2022
Registry last updated
Aug 14, 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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