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

M

Mohammed Ramadan

Status

Completed

Conditions

Partially Edentulous Maxilla
Single Tooth Lost

Treatments

Procedure: guided Conventional drilling-based protocol
Procedure: guided trephination-based drilling protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05295082
FDASU-RecIM012225

Details and patient eligibility

About

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

Full description

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.

Enrollment

22 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

guided trephination-based protocol
Experimental group
Description:
The drilling process will be performed by guided trephination protocol. * An appropriate trephine drill (Helmut Zepf Medizintechnik GmbH, Germany) will be used to create an initial osteotomy. * The guide will be removed, and the depth and angulation of this initial osteotomy will be evaluated. * The final drill of the chosen implant system will be used to complete the osteotomy. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.
Treatment:
Procedure: guided trephination-based drilling protocol
guided conventional drilling-based protocol
Active Comparator group
Description:
The drilling process will be performed by a guided conventional drilling protocol. * Drilling (Neo NaviGuide System - Neobiotech Co. Ltd. Korea) will be performed throughout the guiding sleeve from the first drill to the final drill. * The guide will be removed. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.
Treatment:
Procedure: guided Conventional drilling-based protocol

Trial contacts and locations

1

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Central trial contact

Mohammed Ramadan, bachelor

Data sourced from clinicaltrials.gov

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