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CompletedNCT05670067Updated Mar 11, 2025

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

An interventional study of maxillary tuberosity bone graft (autogenous graft) and Bone graft (xenograft) in Immediate Implant Placement, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2021, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Immediate Implant Placement
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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)

  • Active comparator
    immediate implant with bonegraft (xenograft)

    with immediate implant placement grafting with xenograft will be done

    Procedure: Bone graft (xenograft)

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

06

What researchers measure

Primary outcomes

  1. buccal bone thickness

    measuring the buccal bone thickness using CBCT

    Time frame: at baseline and 9 months

Secondary outcomes

  1. soft tissue assessment using pink esthetic score

    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

    Time frame: 9 months post opertive

  2. patient satisfaction

    questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied

    Time frame: after 9 months

07

Study locations

1 site
  • Faculty of Dentistry Ain Shams University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05670067
Lead sponsor
Ain Shams University
Responsible party
Ahmed Hesham Mohamed (assistant lecturer, Ain Shams University) — Principal investigator
First posted
Jan 4, 2023
Start date
Oct 30, 2021
Primary completion
Nov 23, 2024
Completion
Jan 5, 2025
Last update
Mar 11, 2025

Study contacts

Hala Abu el ela, Prof
study director · Faculty of dentistry ain shams university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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