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CompletedNCT05295082Updated Aug 14, 2024

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

An interventional study of guided trephination-based drilling protocol and guided Conventional drilling-based protocol in Single Tooth Lost and Partially Edentulous Maxilla, sponsored by Mohammed Ramadan. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Mohammed Ramadan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Single Tooth Lost
  • Partially Edentulous Maxilla

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Keywords

  • guided implant
  • surgical guide
  • dental implant
  • dental trephination
  • guided trephination
03

In context

Tooth Loss

224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.

This study's enrollment of 22 is below the median of 30 across 166 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

This is the only study on the registry with Mohammed Ramadan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    guided trephination-based protocol

    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.

    Procedure: guided trephination-based drilling protocol

  • Active comparator
    guided conventional drilling-based protocol

    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.

    Procedure: guided Conventional drilling-based protocol

Interventions

  • Procedureguided trephination-based drilling protocol

    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

  • Procedureguided Conventional drilling-based protocol

    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

06

What researchers measure

Primary outcomes

  1. Horizontal deviation at apex of the implant.

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

    Time frame: immediately after the intervention

  2. •Horizontal deviation at implant shoulder.

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

    Time frame: immediately after the intervention

  3. Angular deviation.

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

    Time frame: immediately after the intervention

Secondary outcomes

  1. The duration of the surgery

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

    Time frame: during the surgery

  2. Satisfaction assessed by the Visual Analogue Scale

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

    Time frame: immediately after the intervention

07

Study locations

1 site
  • AinShams University
    Cairo, Egypt
08

References and documents

Publications

  • Suriyan N, Sarinnaphakorn L, Deeb GR, Bencharit S. Trephination-based, guided surgical implant placement: A clinical study. J Prosthet Dent. 2019 Mar;121(3):411-416. doi: 10.1016/j.prosdent.2018.06.004. Epub 2018 Nov 30. PubMed 30503150 ↗
  • Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x. PubMed 23062136 ↗
  • Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Accuracy of a computer-aided implant surgical technique. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):317-25. doi: 10.11607/prd.1019. PubMed 23593625 ↗

Individual participant data

Plan to share: No — the data that will be shared is the CBCT, virtual planning

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05295082
Lead sponsor
Mohammed Ramadan
Responsible party
Mohammed Ramadan (Principal investigator, Ain Shams University) — Sponsor-investigator
First posted
Mar 24, 2022
Start date
Apr 1, 2022
Primary completion
Jun 20, 2023
Completion
Apr 30, 2024
Last update
Aug 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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