Dental ImplantNCT06295653
Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
A study testing implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane in people with Dental Implant, run by Tanta University at 1 site in Egypt.
Trial summary
The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Apr 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with good systemic health with no contraindication for periodontal surgery.
- No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- Ability to maintain good oral hygiene as evidenced in recall visits.
- Aged 30 to 55 years.
- Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).
Who cannot join
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Smokers.
- Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
- Patients subjected to irradiation in the head and neck area.
- Patients treated or under treatment with intravenous amino bisphosphonates.
- Patient affected by active periodontitis or has poor oral hygiene and motivation.
- Uncontrolled diabetes mellitus.
- Pregnant women or planning become pregnant, and nursing mothers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculity of Dentistry Tanta University
Tanta, Elgarbia, 6620012
Faten a Seddiq, Faculty Dean, 3335631 ext. +20, dean_dent@unv.tanta.edu.eg
ahmed a abdelsayed
About this study
The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.
- Conditions
- Dental Implant
- Being tested
- implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane
- Keywords
- dental implant, Subepithelial Connective Tissue Graft, Amniotic Chorion Membrane, for Peri-implant Mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion MembraneProcedure or surgery
Also called measure mucosal thickness with probe, connective tissue grafting from palate
assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Subepithelial Connective Tissue Graft plus dental implants | Active comparator | implant placement and augment Subepithelial Connective Tissue Graft and suture implant site Receives: Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane |
| Amniotic Chorion Membrane plus dental implant | Active comparator | implant placement and augment Amniotic Chorion Membrane and suture implant site Receives: Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure changes in periimplant mucosal thickness
The primary outcome of interest will be to measure changes (in mm) in horizontal periimplant mucosal thicknesson the buccal aspect of the edentulous alveolar ridge from baseline (BL) (implant placement and grafting) to (3 and 6 month) of post-surgical healing.
Measured: six months
Secondary outcomes (1)
mid-buccal keratinized mucosal width
measure change (in mm) in mid-buccal keratinized mucosal width in an apico-coronal direction
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Helal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295653
- Sponsor's protocol ID
- 7-23
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share the results to determine the difference between the materials used in the research and the possibility of using the best ones
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
- ClinicalTrials.gov ID
- NCT06295653
- Acronym / sponsor ID
- 7-23
- Conditions
- Dental Implant
- Keywords
- dental implant, Subepithelial Connective Tissue Graft, Amniotic Chorion Membrane, for Peri-implant Mucosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Mar 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.
The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous Subepithelial Connective Tissue Graft plus dental implants | Active comparator | Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membraneimplant placement and augment Subepithelial Connective Tissue Graft and suture implant site |
| Amniotic Chorion Membrane plus dental implant | Active comparator | Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membraneimplant placement and augment Amniotic Chorion Membrane and suture implant site |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with good systemic health with no contraindication for periodontal surgery.
- No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- Ability to maintain good oral hygiene as evidenced in recall visits.
- Aged 30 to 55 years.
- Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).
Key exclusion criteria (8 listed)
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Smokers.
- Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
- Patients subjected to irradiation in the head and neck area.
- Patients treated or under treatment with intravenous amino bisphosphonates.
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 and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion MembraneAlso: measure mucosal thickness with probe, connective tissue grafting from palateassess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement. | Procedure or surgery | Amniotic Chorion Membrane plus dental implant, Autogenous Subepithelial Connective Tissue Graft plus dental implants |
Primary outcome
measure changes in periimplant mucosal thickness
Time frame: six months
The primary outcome of interest will be to measure changes (in mm) in horizontal periimplant mucosal thicknesson the buccal aspect of the edentulous alveolar ridge from baseline (BL) (implant placement and grafting) to (3 and 6 month) of post-surgical healing.
1 secondary outcome
mid-buccal keratinized mucosal width
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Yes. share the results to determine the difference between the materials used in the research and the possibility of using the best ones
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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.
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 and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane in people with Dental Implant, run by Tanta 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 8 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 6 Mar 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.
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 ahmed a abdelsayed (+201090609989, ahmedaboelnagah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure changes in periimplant mucosal 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 6 Mar 2024.