Immediate Implant PlacementNCT05670067
Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity
A study testing maxillary tuberosity bone graft (autogenous graft) and Bone graft (xenograft) in people with Immediate Implant Placement, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- maxillary tuberosity bone graft (autogenous graft) and Bone graft (xenograft)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2021to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Conditions
- Immediate Implant Placement
- Being tested
- maxillary tuberosity bone graft (autogenous graft), Bone graft (xenograft)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary tuberosity bone graft (autogenous graft)Procedure or surgery
the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration
Bone graft (xenograft)Procedure or surgery
xenograft is bone graft material that is obtained from porcine, bovine or equine source
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with bone graft (autogenous) | Active comparator | with immediate implant placement autogenous grafting using maxillary tuberosity will be done Receives: Procedure: maxillary tuberosity bone graft (autogenous graft) |
| immediate implant with bonegraft (xenograft) | Active comparator | with immediate implant placement grafting with xenograft will be done Receives: Procedure: Bone graft (xenograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal bone thickness
measuring the buccal bone thickness using CBCT
Measured: at baseline and 9 months
Secondary outcomes (2)
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
Measured: 9 months post opertive
patient satisfaction
questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied
Measured: after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start30 Oct 2021
- Primary completion23 Nov 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two group in which the same procedure is done ( immediate implant placement) using different bone grafts
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hesham Mohamed, Ain Shams University
- Investigators
- Hala Abu el ela, Prof, Study director, Faculty of dentistry ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670067
- Sponsor's protocol ID
- no 948
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05670067
- Acronym / sponsor ID
- no 948
- Conditions
- Immediate Implant Placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two group in which the same procedure is done ( immediate implant placement) using different bone grafts
| Arm | Type | Receives |
|---|---|---|
| immediate implant with bone graft (autogenous) | Active comparator | Procedure: maxillary tuberosity bone graft (autogenous graft)with immediate implant placement autogenous grafting using maxillary tuberosity will be done |
| immediate implant with bonegraft (xenograft) | Active comparator | Procedure: Bone graft (xenograft)with immediate implant placement grafting with xenograft will be done |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maxillary tuberosity bone graft (autogenous graft)the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration | Procedure or surgery | immediate implant with bone graft (autogenous) |
| Bone graft (xenograft)xenograft is bone graft material that is obtained from porcine, bovine or equine source | Procedure or surgery | immediate implant with bonegraft (xenograft) |
Primary outcome
buccal bone thickness
Time frame: at baseline and 9 months
measuring the buccal bone thickness using CBCT
2 secondary outcomes
soft tissue assessment using pink esthetic score
Time frame: 9 months post opertive
patient satisfaction
Time frame: after 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Abu el ela, Prof study director
Faculty of dentistry ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary tuberosity bone graft (autogenous graft) and Bone graft (xenograft) in people with Immediate Implant Placement, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal bone thickness (time frame: at baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.