Dental Implant FailedNCT04102748
Evaluation of Esthetic Outcomes of M-shaped Flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score
A study testing I-incision, M-flap and conventional implant exposure techniques in people with Dental Implant Failed, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- I-incision, M-flap and conventional implant exposure techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Mar 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with osseointegrated dental implant in the anterior maxilla.
- Patients of 20 - 50 years
- Periodontally healthy patients.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate surgical intervention.
Who cannot join
- Intraoral soft and hard tissue pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Esthetic Outcomes of M-flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score (PES) (RCT)
The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES.
Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.
- Conditions
- Dental Implant Failed
- Being tested
- I-incision, M-flap and conventional implant exposure techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-incision, M-flap and conventional implant exposure techniquesProcedure or surgery
Implant uncovering in the second stage using 3 different exposure techniques
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Not described Receives: Procedure: I-incision, M-flap and conventional implant exposure techniques |
| I-incision | Active comparator | Not described Receives: Procedure: I-incision, M-flap and conventional implant exposure techniques |
| M-flap | Active comparator | Not described Receives: Procedure: I-incision, M-flap and conventional implant exposure techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
PES
Esthetic outcomes around implant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Jan 2019
- Primary completion15 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ezzat Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102748
- Sponsor's protocol ID
- Ezzat Implant Master Thesis
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Esthetic Outcomes of M-flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score (PES) (RCT)
- ClinicalTrials.gov ID
- NCT04102748
- Acronym / sponsor ID
- Ezzat Implant Master Thesis
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 25 Sep 2019 (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.
The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES.
Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: I-incision, M-flap and conventional implant exposure techniques |
| I-incision | Active comparator | Procedure: I-incision, M-flap and conventional implant exposure techniques |
| M-flap | Active comparator | Procedure: I-incision, M-flap and conventional implant exposure techniques |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with osseointegrated dental implant in the anterior maxilla.
- Patients of 20 - 50 years
- Periodontally healthy patients.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate surgical intervention.
Key exclusion criteria (5 listed)
- Intraoral soft and hard tissue pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
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 |
|---|---|---|
| I-incision, M-flap and conventional implant exposure techniquesImplant uncovering in the second stage using 3 different exposure techniques | Procedure or surgery | Conventional, I-incision, M-flap |
Primary outcome
PES
Time frame: 3 months
Esthetic outcomes around implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 I-incision, M-flap and conventional implant exposure techniques in people with Dental Implant Failed, 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 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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?
Results are not available in the source record.
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?
PES (time frame: 3 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 25 Sep 2019.