Missing TeethNCT07080177
Assessment of Hard and Soft Tissue Changes Following XCM Versus FGG Simultaneous With Delayed Dental Implant Placement
A study testing Free gingival graft simultaneous with delayed implant placement and Xenogeneic collagen matrix simultaneous with delayed implant placement in people with Missing Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule. Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Free gingival graft simultaneous with delayed implant placement and Xenogeneic collagen matrix simultaneous with delayed implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults above the age of 18 years.
- Presence of 2mm or less of keratinized tissue width
- Sufficient alveolar ridge width minimum of 6 mm
- Patients with good oral hygiene as evidenced by plaque index (PI)<1 and showing cooperation or compliance with treatment.
Who cannot join
- Patients diagnosed with periodontal diseases (Caton et al., 2018).
- Acute active infection at implant sites
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy
- Patients with parafunctional habits.
- Smokers (≥10 cigarettes per day),
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maged M Seleet, PhD contact
About this study
Official title: Assessment of Hard and Soft Tissue Changes Following Xenogeneic Collagen Membrane Versus Free Gingival Graft Simultaneous With Delayed Dental Implant Placement: Randomized Controlled Clinical Trial
Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule.
Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Although the role of width of KM in maintaining peri-implant health is a controversial topic, the majority of high-level evidence has suggested that a minimum KM width (KMW) of 2 mm around the dental implants is critical to maintain peri-implant health and the long-term survival of dental implants.
Read the detailed description
This study will be carried out on patients attending outpatient clinic of Oral maxillofacial surgery and Periodontology Departments, Faculty of Dentistry. Modern University for Technology and Information, Cairo, Egypt.
P: Healthy patients with posterior missing teeth with deficient keratinized tissue to receive delayed dental implant placement I: Xenogeneic collagen membrane (XCM) simultaneous with delayed implant placement C: Free gingival graft (FGG) simultaneous with delayed implant placement O: Keratinized tissue width (KMW), graft shrinkage (GS), marginal bone loss (MBL) T- One year S- Randomized controlled clinical trial.
Eligible patients will be divided into equal proportions between control group and test group.
The control group "Group 1" will receive FGG simultaneous with implant placement The test group "Group 2" will receive XCM simultaneous with implant placement
- Conditions
- Missing Teeth
- Being tested
- Free gingival graft simultaneous with delayed implant placement, Xenogeneic collagen matrix simultaneous with delayed implant placement
- Keywords
- xenogeneic collagen membrane, free gingival graft, xenogeneic collagen matrices, simultaneous implant placement
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft simultaneous with delayed implant placementProcedure or surgery
XCM grafts (of bovine origin)
Xenogeneic collagen matrix simultaneous with delayed implant placementProcedure or surgery
A FGG will be harvested from the palate between first premolar and first molar
| Study group | Role | What they receive |
|---|---|---|
| Xenogeneic collagen matrix simultaneous with delayed implant placement | Experimental | Tissue punch technique implants will be placed. XCM grafts (of bovine origin) will be trimmed to the required dimensions and will be fixed to the periosteum and sutured to the buccal peri-implant mucosa Receives: Procedure: Xenogeneic collagen matrix simultaneous with delayed implant placement |
| Free gingival graft simultaneous with delayed implant placement | Active comparator | Tissue punch technique implants will be placed. A FGG will be harvested from the palate then the outlined graft will be placed and sutured to the recipient bed of the buccal peri-implant mucosa Receives: Procedure: Free gingival graft simultaneous with delayed implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue width
mm
Measured: One year
graft shrinkage
precentage
Measured: One year
marginal bone loss
mm
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start22 Sep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- MTI University
- Responsible party
- Principal investigator, Parryhan Mohamed Abdelsamie, MTI University
- Investigators
- Parryhan M Abdelsamie, PhD, Principal investigator, MTI UniversityMaged M Seleet, PhD, Principal investigator, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080177
- Sponsor's protocol ID
- MTI
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hard and Soft Tissue Changes Following Xenogeneic Collagen Membrane Versus Free Gingival Graft Simultaneous With Delayed Dental Implant Placement: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07080177
- Acronym / sponsor ID
- MTI
- Conditions
- Missing Teeth
- Keywords
- xenogeneic collagen membrane, free gingival graft, xenogeneic collagen matrices, simultaneous implant placement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- MTI University
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule.
Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Although the role of width of KM in maintaining peri-implant health is a controversial topic, the majority of high-level evidence has suggested that a minimum KM width (KMW) of 2 mm around the dental implants is critical to maintain peri-implant health and the long-term survival of dental implants.
Detailed description
This study will be carried out on patients attending outpatient clinic of Oral maxillofacial surgery and Periodontology Departments, Faculty of Dentistry. Modern University for Technology and Information, Cairo, Egypt.
P: Healthy patients with posterior missing teeth with deficient keratinized tissue to receive delayed dental implant placement I: Xenogeneic collagen membrane (XCM) simultaneous with delayed implant placement C: Free gingival graft (FGG) simultaneous with delayed implant placement O: Keratinized tissue width (KMW), graft shrinkage (GS), marginal bone loss (MBL) T- One year S- Randomized controlled clinical trial.
Eligible patients will be divided into equal proportions between control group and test group.
The control group "Group 1" will receive FGG simultaneous with implant placement The test group "Group 2" will receive XCM simultaneous with implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenogeneic collagen matrix simultaneous with delayed implant placement | Experimental | Procedure: Xenogeneic collagen matrix simultaneous with delayed implant placementTissue punch technique implants will be placed. XCM grafts (of bovine origin) will be trimmed to the required dimensions and will be fixed to the periosteum and sutured to the buccal peri-implant mucosa |
| Free gingival graft simultaneous with delayed implant placement | Active comparator | Procedure: Free gingival graft simultaneous with delayed implant placementTissue punch technique implants will be placed. A FGG will be harvested from the palate then the outlined graft will be placed and sutured to the recipient bed of the buccal peri-implant mucosa |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults above the age of 18 years.
- Presence of 2mm or less of keratinized tissue width
- Sufficient alveolar ridge width minimum of 6 mm
- Patients with good oral hygiene as evidenced by plaque index (PI)<1 and showing cooperation or compliance with treatment.
Key exclusion criteria (5 listed)
- Patients diagnosed with periodontal diseases (Caton et al., 2018).
- Acute active infection at implant sites
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy
- Patients with parafunctional habits.
- Smokers (≥10 cigarettes per day),
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 |
|---|---|---|
| Free gingival graft simultaneous with delayed implant placementXCM grafts (of bovine origin) | Procedure or surgery | Free gingival graft simultaneous with delayed implant placement |
| Xenogeneic collagen matrix simultaneous with delayed implant placementA FGG will be harvested from the palate between first premolar and first molar | Procedure or surgery | Xenogeneic collagen matrix simultaneous with delayed implant placement |
Primary outcome
Keratinized tissue width
Time frame: One year
mm
graft shrinkage
Time frame: One year
precentage
marginal bone loss
Time frame: One year
mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Missing Teeth
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Not yet recruitingPhase 4
S-TiUltra Implant Study
Missing Tooth/Teeth
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
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.
Maged M Seleet, PhD contact
Parryhan M Abdelsamie, PhD principal investigator
MTI University
Maged M Seleet, PhD principal investigator
MTI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft simultaneous with delayed implant placement and Xenogeneic collagen matrix simultaneous with delayed implant placement in people with Missing Teeth, 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 4 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parryhan M Abdelsamie, PhD (01003082353, Parryhan.abdelsamie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratinized tissue width (time frame: One year). The study lists 3 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 12 Sep 2025.