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

Partially Edentulous Maxilla Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05295082
• Other study ID #: FDASU-RecIM012225
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: June 2023

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: Mohammed Ramadan, bachelor
• Phone: 01003274889
• Email: dentistmh93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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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Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Maxilla
• Single Tooth Lost
• Tooth Loss

Intervention

Procedure:
• guided 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
• guided 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

Locations

Country	Name	City	State
Egypt	AinShams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Ramadan

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately after the intervention
Primary	•Horizontal deviation at implant shoulder.	measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position	immediately after the intervention
Primary	Angular deviation.	measure the Angular deviation of the implant between the virtual planning position and the actual implant position	immediately after the intervention
Secondary	The duration of the surgery	measure the time of the surgery from the first drill to the implant placement	during the surgery
Secondary	Satisfaction assessed by the Visual Analogue Scale	measure the patient satisfaction score on terms of pain and discomfort from 1 to 10	immediately after the intervention