Early Versus Conventional Loading for Fully Guided Immediate Implant Placement

NCT ID: NCT06281535

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-06-15

Brief 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.

Detailed 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.

Conditions

Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Early loading group

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement.

Group Type: EXPERIMENTAL

Implant loading

Intervention Type: DEVICE

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

Conventional loading group

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement.

Group Type: ACTIVE_COMPARATOR

Implant loading

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Adel Salah Khattab

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doaa Adel-Khattab, PhD

Role: STUDY_CHAIR

Associate Professor Faculty of Dentistry, Ain Shams University

Abdel Rahman Khalaf, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Faculty of Dentistry, Assiut University

Central Contacts

Doaa Adel-Khattab, PhD

Role: CONTACT

dr.doaa.adel-khattab@dent.asu.edu.eg

01006814258

Abdel Rahman Khalaf, PHD

Role: CONTACT

abdodent84@yahoo.com

0116589954

Other Identifiers

21789

Identifier Type: -

Identifier Source: org_study_id