Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity

NCT ID: NCT05670067

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2025-01-05

Brief Summary

In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative

Detailed Description

immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I&II

Conditions

Immediate Implant Placement

Study Design

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

Study Groups

immediate implant with bone graft (autogenous)

with immediate implant placement autogenous grafting using maxillary tuberosity will be done

Group Type: ACTIVE_COMPARATOR

maxillary tuberosity bone graft (autogenous graft)

Intervention Type: PROCEDURE

the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration

immediate implant with bonegraft (xenograft)

with immediate implant placement grafting with xenograft will be done

Group Type: ACTIVE_COMPARATOR

Bone graft (xenograft)

Intervention Type: PROCEDURE

xenograft is bone graft material that is obtained from porcine, bovine or equine source

Interventions

maxillary tuberosity bone graft (autogenous graft)

the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration

Intervention Type: PROCEDURE

Bone graft (xenograft)

xenograft is bone graft material that is obtained from porcine, bovine or equine source

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
• Age range (20-40) years.
• Good compliance with the plaque control instructions following initial therapy.
• Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 & 2)
• Availability for follow up and maintenance program.

Exclusion Criteria

• Peri apically infected teeth
• Presence of smoking habit.
• Presence of occlusal interferences.
• Pregnant females.
• Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hesham Mohamed

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Abu el ela, Prof

Role: STUDY_DIRECTOR

Faculty of dentistry ain shams university

Locations

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

no 948

Identifier Type: -

Identifier Source: org_study_id