Implant or Graft; RejectionNCT05274256
Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation
A study testing implant placement with simultaneous soft tissue augmentation in people with Implant or Graft; Rejection, run by Cairo University at 1 site in Egypt.
Trial summary
Tooth extraction in maxillary esthetic zone is accomplished with great dimensional changes of the alveolar ridge, different procedures have been tested to compensate these dimensional alteration, such as Hard bone augmentation, Soft tissue augmentation Or augmentation of both together. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant or Graft; Rejection
- What is being tested?
- implant placement with simultaneous soft tissue augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Mar 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient of both sexes with missing teeth in the maxillary aesthetic zone.
Who cannot join
- Patients with systemic disease that may affect bone quality or bone healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation Using De-epithelialized Free Gingival Graft and Its Effect on Esthetics. a Case Series Study
Tooth extraction in maxillary esthetic zone is accomplished with great dimensional changes of the alveolar ridge, different procedures have been tested to compensate these dimensional alteration, such as Hard bone augmentation, Soft tissue augmentation Or augmentation of both together. Hence, the present study aimed to evaluate pink esthetic score, clinical implant stability and bucco-palatal dimensional changes in the maxillary esthetic zone treated by implant placement with simultaneous soft tissue augmentation using de-epithelialized free gingival graft.
- Conditions
- Implant or Graft; Rejection
- Being tested
- implant placement with simultaneous soft tissue augmentation
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement with simultaneous soft tissue augmentationProcedure or surgery
implant placement with simultaneous soft tissue augmentation using De-epithelialized free gingival graft and immediate temporization in the maxillary aesthetic zone .
| Study group | Role | What they receive |
|---|---|---|
| patients with missing teeth in maxillary aesthetic zone | Other | Not described Receives: Procedure: implant placement with simultaneous soft tissue augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score
pink esthetic score evaluated pre-operative and 6 month post-operative (PES scale 0-1-2 , ''2'' the best , ''0'' the worst
Measured: 6 month
Secondary outcomes (1)
Implant stability quotient
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant or Graft; RejectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Maher Hakeem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274256
- Sponsor's protocol ID
- 1975
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation Using De-epithelialized Free Gingival Graft and Its Effect on Esthetics. a Case Series Study
- ClinicalTrials.gov ID
- NCT05274256
- Acronym / sponsor ID
- 1975
- Conditions
- Implant or Graft; Rejection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Mar 2022 (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.
Tooth extraction in maxillary esthetic zone is accomplished with great dimensional changes of the alveolar ridge, different procedures have been tested to compensate these dimensional alteration, such as Hard bone augmentation, Soft tissue augmentation Or augmentation of both together. Hence, the present study aimed to evaluate pink esthetic score, clinical implant stability and bucco-palatal dimensional changes in the maxillary esthetic zone treated by implant placement with simultaneous soft tissue augmentation using de-epithelialized free gingival graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with missing teeth in maxillary aesthetic zone | Other | Procedure: implant placement with simultaneous soft tissue augmentation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient of both sexes with missing teeth in the maxillary aesthetic zone.
Key exclusion criteria (1 listed)
- Patients with systemic disease that may affect bone quality or bone healing.
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 |
|---|---|---|
| implant placement with simultaneous soft tissue augmentationimplant placement with simultaneous soft tissue augmentation using De-epithelialized free gingival graft and immediate temporization in the maxillary aesthetic zone . | Procedure or surgery | patients with missing teeth in maxillary aesthetic zone |
Primary outcome
pink esthetic score
Time frame: 6 month
pink esthetic score evaluated pre-operative and 6 month post-operative (PES scale 0-1-2 , ''2'' the best , ''0'' the worst
1 secondary outcome
Implant stability quotient
Time frame: 6 month
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 10 Mar 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement with simultaneous soft tissue augmentation in people with Implant or Graft; Rejection, run by Cairo 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 1 inclusion and 1 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 10 Mar 2022. 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?
pink esthetic score (time frame: 6 month). 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 10 Mar 2022.