Immediate ImplantPhase 2NCT06588998
Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial
A Phase 2 study testing Xengenic Cortical membranes and connective tissue graft in people with Immediate Implant and Connective Tissue Graft, run by Amr Anwar Mohamed Ellithy Yousef at 1 site in Egypt.
Trial summary
Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Immediate Implant, Connective Tissue Graft
- What is being tested?
- Xengenic Cortical membranes and connective tissue graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Dec 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.
Who cannot join
- •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
bassem nabil elfahl, PHD contact
About this study
Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.
Read the detailed description
Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.
- Conditions
- Immediate Implant, Connective Tissue Graft
- Being tested
- Xengenic Cortical membranes, connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xengenic Cortical membranesDevice
Also called Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
soft tissue surgery around dental implant dehiscence
connective tissue graftProcedure or surgery
soft tissue surgery around dental implant dehiscence
| Study group | Role | What they receive |
|---|---|---|
| Xengenic Cortical membranes | Experimental | Not described Receives: Device: Xengenic Cortical membranes |
| connective tissue graft | Active comparator | Not described Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri implant soft tissue thickness
Measured: six months
Secondary outcomes (1)
pink esthetic score
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amr Anwar Mohamed Ellithy Yousef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr Anwar Mohamed Ellithy Yousef, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588998
- Sponsor's protocol ID
- peri-implant_1
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06588998
- Acronym / sponsor ID
- peri-implant_1
- Conditions
- Immediate Implant, Connective Tissue Graft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amr Anwar Mohamed Ellithy YousefUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.
Detailed description
Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xengenic Cortical membranes | Experimental | Device: Xengenic Cortical membranes |
| connective tissue graft | Active comparator | Procedure: connective tissue graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.
Key exclusion criteria (1 listed)
- •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.
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 |
|---|---|---|
| Xengenic Cortical membranesAlso: Osteobiol ,flexible xenograft cortical sheet from Technoss,USAsoft tissue surgery around dental implant dehiscence | Device | Xengenic Cortical membranes |
| connective tissue graftsoft tissue surgery around dental implant dehiscence | Procedure or surgery | connective tissue graft |
Primary outcome
peri implant soft tissue thickness
Time frame: six months
1 secondary outcome
pink esthetic score
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
bassem nabil elfahl, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xengenic Cortical membranes and connective tissue graft in people with Immediate Implant and Connective Tissue Graft, run by Amr Anwar Mohamed Ellithy Yousef 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact amr anwar ellithy, MSC (00201066767062, amr.yousef@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri implant soft tissue thickness (time frame: six 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 19 Sep 2024.