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NCT06281535 Clinical Trial

Early Versus Conventional Loading for Fully Guided Immediate Implant Placement

Dental Implant Clinical Trial

Official title:
Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06281535
Other study ID # 21789
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 20, 2024
Est. completion date June 15, 2024

Study information
Verified date February 2024
Source Ain Shams University
Contact Doaa Adel-Khattab, PhD
Phone 01006814258
Email dr.doaa.adel-khattab@dent.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.

Description:

The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date June 15, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - Patients age range from 20-60 years. - Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture. - Primary implant stability is above 30 Ncm. Exclusion Criteria: - History or presence of severe uncontrolled systemic disease. - Heavy smokers (>10 cigarettes per day) or alcohol/drug abusers. - Poor oral hygiene. - Acute periapical infection.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Implant loading
Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ain Shams University Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Implant stability Degree of implant stability will be measured by Osstell device as a scale from 1 to 100 2 and 3 months following implant placement
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