Keratinized MucosaPhase 1NCT06753084
Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant
A Phase 1 study testing Alloderm in people with Keratinized Mucosa, run by ahmed amer at 2 sites in Egypt.
Trial summary
Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant. Primary Outcome: Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Keratinized Mucosa
- What is being tested?
- Alloderm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2023to 25 Jul 2024
- Phase
- Phase 1
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.
- 2- Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.
- 5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
Who cannot join
- 1- Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Misr university for science and technology
Giza, NJ, 08989
Misr university for science and technology
Giza, 00202
About this study
Official title: Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study
Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant.
Primary Outcome:
Read more
Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation.
Secondary Outcome:
- Crestal bone change (CBC)
- Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI) PICOT
P: Population:
Patient with suitable ridge dimension for delayed implant placement.
I: Intervention:
Implant insertion followed by porcine collagen matrix soft tissue augmentation
C: Control:
Autogenous FGG
O: Outcomes
- Enhancing keratinized mucosal width and thickness
- Evaluating :
- Crestal bone change (CBC)
- perimplant Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI)
- Modified PES. T: Time A 6 months follow up .
Read the detailed description
this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT
- Conditions
- Keratinized Mucosa
- Being tested
- Alloderm
- Keywords
- keratinized tissue width , porcine collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllodermProcedure or surgery
the study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group
| Study group | Role | What they receive |
|---|---|---|
| KTW augmentation using FGG | Active comparator | KTW augmentation using apically positioned flap combined with FGG from palatal mucosa Receives: Procedure: Alloderm |
| KTW augmentation using porcine collagen matrix | Experimental | KTW augmentation using apically positioned flap combined with porcine collagen matrix Receives: Procedure: Alloderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized mucosa width
before the operation reading , immediately after operation , 1 month follow up , 3 months follow up and 6 months follow up
the reading will done using periodontal probe
Measured: 1 month , 3 month , 6 months follow up
keratinized tissue thickness
measures the Keratinized tissue thickness using periodontal probe
Measured: 1 month , 3 month , 6 months follow up
Secondary outcomes (3)
probing depth for adjacent teeth
probing depth for adjacent teeth
Measured: 6 months
bleeding on probingn
bleeding on probing for this patient is mesure using papillary bleeding index.
Measured: 1 month , 3 month , 6 months follow up
crestal bone loss around dental implant
measuring crestal bone loss around implant using CBCT and periapical xray
Measured: 1 month , 3 month , 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Nov 2023
- Primary completion1 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratinized MucosaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- ahmed amer
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Sponsor-investigator, ahmed amer, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753084
- Sponsor's protocol ID
- KTW Managment
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after thesis discussion we will decide
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06753084
- Acronym / sponsor ID
- KTW Managment
- Conditions
- Keratinized Mucosa
- Keywords
- keratinized tissue width , porcine collagen matrix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ahmed amerUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 31 Dec 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.
Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant.
Primary Outcome:
Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation.
Secondary Outcome:
- Crestal bone change (CBC)
- Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI) PICOT
P: Population:
Patient with suitable ridge dimension for delayed implant placement.
I: Intervention:
Implant insertion followed by porcine collagen matrix soft tissue augmentation
C: Control:
Autogenous FGG
O: Outcomes
- Enhancing keratinized mucosal width and thickness
- Evaluating :
- Crestal bone change (CBC)
- perimplant Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI)
- Modified PES. T: Time A 6 months follow up .
Detailed description
this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KTW augmentation using FGG | Active comparator | Procedure: AllodermKTW augmentation using apically positioned flap combined with FGG from palatal mucosa |
| KTW augmentation using porcine collagen matrix | Experimental | Procedure: AllodermKTW augmentation using apically positioned flap combined with porcine collagen matrix |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.
- 2- Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.
- 5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
Key exclusion criteria (1 listed)
- 1- Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.
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 |
|---|---|---|
| Allodermthe study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group | Procedure or surgery | KTW augmentation using FGG, KTW augmentation using porcine collagen matrix |
Primary outcome
Keratinized mucosa width
Time frame: 1 month , 3 month , 6 months follow up
before the operation reading , immediately after operation , 1 month follow up , 3 months follow up and 6 months follow up the reading will done using periodontal probe
keratinized tissue thickness
Time frame: 1 month , 3 month , 6 months follow up
measures the Keratinized tissue thickness using periodontal probe
3 secondary outcomes
probing depth for adjacent teeth
Time frame: 6 months
bleeding on probingn
Time frame: 1 month , 3 month , 6 months follow up
crestal bone loss around dental implant
Time frame: 1 month , 3 month , 6 months follow up
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 31 Dec 2024.
- Individual participant dataSharing planned: Undecided. after thesis discussion we will decide
Related trials for Keratinized Mucosa
Not yet recruiting
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Keratinized Mucosa Deficiency, Peri-implant Soft Tissue
Recruiting
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa
Active, not recruiting
Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa
Peri-Implantational Loss, Surgical Wound
Recruiting
Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
Peri-implantitis, Soft Tissue Augmentation at Dental Implants
Active, not recruiting
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Gingival Recession, Lack of Keratinized Gingiva
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alloderm in people with Keratinized Mucosa, run by ahmed amer at 2 sites 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 3 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Keratinized mucosa width (time frame: 1 month , 3 month , 6 months follow up). The study lists 2 primary outcomes in all. 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 31 Dec 2024.