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

Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft From the Maxillary Tuberosity Simultaneous With Immediate Implant Placement ( a Randomized Clinical Clinical Study)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Immediate Implant Placement
• Intervention / Treatment: Procedure: maxillary tuberosity bone graft (autogenous graft); Procedure: Bone graft (xenograft)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: immediate implant with bone graft (autogenous); with immediate implant placement autogenous grafting using maxillary tuberosity will be done	Procedure: maxillary tuberosity bone graft (autogenous graft); the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration
Active Comparator: immediate implant with bonegraft (xenograft); with immediate implant placement grafting with xenograft will be done	Procedure: Bone graft (xenograft); xenograft is bone graft material that is obtained from porcine, bovine or equine source

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
buccal bone thickness	measuring the buccal bone thickness using CBCT	at baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volumetric assessment of soft tissue	assessment of the soft tissue thickness after soft tissue augmentation using sub- epithelial connective tissue	6 months post opertive
patient satisfaction	questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied	after 6 month

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Hala Abu el ela, Prof, Faculty of Dentistry Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2021
• Primary Completion (Actual): November 23, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: no 948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No