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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05670067
Enrollment
24
Registered
2023-01-04
Start date
2021-10-30
Completion date
2025-01-05
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant Placement

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

Interventions

PROCEDUREmaxillary tuberosity bone graft (autogenous graft)

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

PROCEDUREBone graft (xenograft)

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the outcome assessor will not know the grouping of the study he will only know that immediate implant was placed in both groups

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
buccal bone thicknessat baseline and 9 monthsmeasuring the buccal bone thickness using CBCT

Secondary

MeasureTime frameDescription
soft tissue assessment using pink esthetic score9 months post opertiveThe 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 satisfactionafter 9 monthsquestionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026