Clinical trial NCT05295082: Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement
Official title: Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Tooth Lost
Partially Edentulous Maxilla
Keywords: guided implant
surgical guide
dental implant
dental trephination
guided trephination
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: guided dental implant placement through guided trephine-based implant site preparation
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

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Primary outcomes:
measure: Horizontal deviation at apex of the implant.
timeFrame: immediately after the intervention
measure: •Horizontal deviation at implant shoulder.
timeFrame: immediately after the intervention
measure: Angular deviation.
timeFrame: immediately after the intervention
Secondary outcomes:
measure: The duration of the surgery
timeFrame: during the surgery
measure: Satisfaction assessed by the Visual Analogue Scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.