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

NCT05670067 | Completed

• 1 other identifier: no 948
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Immediate Implant Placement

Outcome Measures

Primary Outcomes (1)

• buccal bone thickness

  measuring the buccal bone thickness using CBCT

  at baseline and 9 months

Secondary Outcomes (2)

• soft tissue assessment using pink esthetic score

  9 months post opertive

• patient satisfaction

  after 9 months

Study Arms (2)

immediate implant with bone graft (autogenous)

ACTIVE COMPARATOR

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

Procedure: maxillary tuberosity bone graft (autogenous graft)

immediate implant with bonegraft (xenograft)

ACTIVE COMPARATOR

with immediate implant placement grafting with xenograft will be done

Procedure: Bone graft (xenograft)

Interventions

maxillary tuberosity bone graft (autogenous graft) PROCEDURE

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

immediate implant with bone graft (autogenous)

Bone graft (xenograft) PROCEDURE

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

immediate implant with bonegraft (xenograft)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Transplantation, Autologous; Bone Transplantation; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures

Study Officials

• Hala Abu el ela, Prof

  Faculty of dentistry ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessor will not know the grouping of the study he will only know that immediate implant was placed in both groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: two group in which the same procedure is done ( immediate implant placement) using different bone grafts

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: January 4, 2023
• Study Start: October 30, 2021
• Primary Completion: November 23, 2024
• Study Completion: January 5, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)