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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03220815
Other study ID # cbc.cairouni
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 15, 2017
Last updated July 15, 2017
Start date July 2016
Est. completion date September 2017

Study information

Verified date July 2017
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

- for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .

- In the study group: implant will be inserted in the low speed osteotomy site. • In the control group: implants will be inserted in the conventional prepared osteotomy site.

- For both groups there is no surgical guide used.

- The flap will then be copiously irrigated with saline in preparation for closure.

- The flap will then be closed using interrupted 4/0 resorbable sutures.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients restoring missing maxillary teeth with implant placement.

- Both sexes.

- Age: 25-45

- Mesio-distal dimensions: Not less than 6 mm

- Bone Height: Not less than 12 mm

- Bucco-lingual dimensions: Not less than 8mm

- All measures will be assessed using CBCT.

Exclusion Criteria:

- Sites needing bone grafting or augmentation.

- Heavy smokers more than 20 cigarettes per day.

- Patients with systemic disease that may affect normal healing.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Drilling at low speed

Conventional drilling at high speed


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary crestal bone loss measurement from radiographic analysis using digital periapical x-ray [Time Frame: 6 month]
Secondary patient morbidity after procedure pain value on pain scale [Time Frame: 1 day]
Secondary Implant stability value resonance frequency analysis using osstell [Time Frame: 3 month]
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