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

Not Applicable

Completed

• Conditions: Immediate Implant Placement
• Interventions: Procedure: maxillary tuberosity bone graft (autogenous graft); Procedure: Bone graft (xenograft)

• Registration Number: NCT05670067
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2021-10-30
• Study First Submitted: 2022-12-11
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2023-01-04
• Primary Completion: 2024-11-23
• Study Completion: 2025-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implant with bone graft (autogenous)	maxillary tuberosity bone graft (autogenous graft)	with immediate implant placement autogenous grafting using maxillary tuberosity will be done
immediate implant with bonegraft (xenograft)	Bone graft (xenograft)	with immediate implant placement grafting with xenograft will be done

Primary Outcome Measures

Name	Time	Method
buccal bone thickness	at baseline and 9 months	measuring the buccal bone thickness using CBCT

Secondary Outcome Measures

Name	Time	Method
soft tissue assessment using pink esthetic score	9 months post opertive	The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency, Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
patient satisfaction	after 9 months	questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied

Trial Locations

Locations (1)

Faculty of Dentistry Ain Shams University; 🇪🇬 Cairo, Egypt