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

Immediate Implant Placement Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05670067
• Other study ID #: no 948
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2023
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Immediate Implant Placement

Intervention

Procedure:
• maxillary tuberosity bone graft (autogenous graft)
the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration
• Bone graft (xenograft)
xenograft is bone graft material that is obtained from porcine, bovine or equine source

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	buccal bone thickness	measuring the buccal bone thickness using CBCT	at baseline and 6 months
Secondary	volumetric assessment of soft tissue	assessment of the soft tissue thickness after soft tissue augmentation using sub- epithelial connective tissue	6 months post opertive
Secondary	patient satisfaction	questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied	after 6 month