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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06334081
Other study ID # A02040230S
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 29, 2023
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants


Description:

16 dental implants were inserted in 16 patients were divided into two groups: Group A: 8 dental implants were inserted using undersized drilling technique and Group B: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding Clinical Evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months. implant stability, implant probing depth, bleeding index. Radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with missed one or more posterior maxillary tooth. - Be older than 18 years and of residual bone height more than10 mm. - Patients with good oral hygiene and willing to participate in the follow-up sessions. - Patients with adequate mesio-distal width and inter-arch space. - Patients without any para-functional habits such as clenching and bruxism. Exclusion Criteria: - Patients whose proposed surgical site had any pathological lesion or root tips. - Drug or alcohol abuse. - Patients with uncontrolled systemic diseases. - Pregnant patients. - Tobacco use more than fourteen cigarettes daily.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
undersized drilling technique
In group A The implant site preparation was made according to the protocol of the manufacturer except that the final drill was omitted. The drilling was done using a low speed reduction, high torque with coolant contra-angle hand piece with surgical motor unit. Speed of drilling was 800-1200 rpm.
single drilling technique
In group B The implant bed was prepared using the new specially designed drills. First, the use of the guide drill of length 3.5mm with speed of 800 rpm and torque of 35 nm, then the use of the one drill of the same diameter of the selected implant size to the full length of the osteotomy site.

Locations

Country Name City State
Egypt Heba Elsheikh Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary bone density measurement cbct will be done to evaluate difference in bone density 6 month
Primary marginal bone loss cbct will be done to evaluate marginal bone loss 6 month
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