Alveolar Bone LossNCT07024186
Xenogenic Collagen Matrix vs. Connective Tissue Graft for Soft Tissue Augmentation Around Early Maxillary Implants
A study testing Xenogeneic Collagen Matrix and subepithelial connective tissue graft in people with Alveolar Bone Loss and Gingival Recession, run by Minia University at 1 site in Egypt.
Trial summary
This study compares two methods used to improve gingival tissue around dental implants placed in (the maxillary esthetic zone). After a tooth is removed and a dental implant is placed early (usually 4-8 weeks later), additional soft tissue is sometimes needed to ensure the implant looks natural and functions well. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Alveolar Bone Loss, Gingival Recession, Peri-implant Mucositis
- What is being tested?
- Xenogeneic Collagen Matrix and subepithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Mar 2022to 20 Feb 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-restorable or hopeless teeth from maxillary anterior to first premolar due to one or more of the following:
- Extensive caries
- Root fractures
- Inability to perform functional crown lengthening due to gingival zenith line with high gingival display
- Improper crown-to-root ratio due to bone removal leading to aesthetic or restorative failure
- Patients aged 25-55 years
- Both male and female patients
- Thin tissue biotype
Who cannot join
- Pregnant women
- Smokers
- Presence of persistent chronic infection at the implant site
- Patients in the growth phase with partially erupted teeth
- Patients with parafunctional habits such as bruxism or clenching that may overload the implant
- Patients with insufficient vertical inter-arch space in centric occlusion to accommodate restorative components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Augmentation by Xenogenic Collagen Matrix Versus Sub Epithelial Connective Tissue Graft Around Early Implant Placement in Maxillary Esthetic Zone
This study compares two methods used to improve gingival tissue around dental implants placed in (the maxillary esthetic zone). After a tooth is removed and a dental implant is placed early (usually 4-8 weeks later), additional soft tissue is sometimes needed to ensure the implant looks natural and functions well. The two techniques being studied are:
Subepithelial connective tissue graft (SCTG) - where tissue is taken from the patient's own mouth (usually the palate)
Read more
Xenogeneic collagen matrix (XCM) - a processed collagen material from animals, used as a substitute for the patient's own tissue.
The goal is to see which method is better in terms of gingival thickness, esthetic appearance, healing, and patient comfort. This research may help dentists choose the most effective and comfortable treatment for their patients.
Read the detailed description
Dental implants in the anterior maxillary region (esthetic zone) are commonly used to replace missing teeth. When implants are placed using the early placement protocol (typically 4-8 weeks after tooth extraction), additional soft tissue volume may be required to ensure an esthetically pleasing and functionally stable result.
Soft tissue augmentation can be achieved using:
Subepithelial connective tissue grafts (SCTG): A technique that involves harvesting tissue from the patient's own palate and placing it around the implant to improve gingival thickness and contour.
Xenogeneic collagen matrix (XCM): A biocompatible, animal-derived collagen scaffold designed to substitute for autologous tissue, reducing patient morbidity and surgical time.
This study is a prospective, randomized, controlled, parallel-arm clinical trial conducted at Minia University, Faculty of Dentistry. Eligible patients missing a single tooth in the anterior maxilla with a thin gingival biotype and requiring early implant placement were recruited. A total of 20 patients were randomly assigned into two groups (10 per group):
Group 1 (Control): Received subepithelial connective tissue graft harvested from the palate using the single-incision technique.
Group 2 (Test): Received xenogeneic collagen matrix (Mucoderm®) adapted and inserted into the grafting site.
Outcome Measures:
Primary Outcome:
Change in gingival thickness (GT) at 12 months post-surgery, measured via transgingival probing using a standardized protocol.
Secondary Outcomes:
Change in width of keratinized tissue (KTW)
Esthetic outcome (using clinical photographs and standardized scoring systems, e.g., Pink Esthetic Score)
Post-operative healing and complications
Patient-reported outcomes regarding comfort, pain, and satisfaction (using Visual Analog Scale questionnaires)
Clinical and radiographic assessments were performed at baseline, 6 months, and 12 months post-implant placement.
Ethical approval was obtained from the Research Ethics Committee of Minia University, and all participants provided informed consent. The study adheres to the Declaration of Helsinki and ICH-GCP guidelines.
This research aims to provide evidence on whether xenogeneic collagen matrix can serve as a viable, less invasive alternative to autogenous tissue grafts in implant dentistry, especially for cases with esthetic demand and thin soft tissue biotype.
- Being tested
- Xenogeneic Collagen Matrix, subepithelial connective tissue graft
- Keywords
- Xenogenic Collagen Matrix, Connective Tissue Graft, Soft Tissue Augmentation
- Medical subject headings
- Alveolar Bone Loss, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogeneic Collagen MatrixProcedure or surgery
Xenogeneic Collagen Matrix The xenogeneic collagen matrix is a biomaterial used to promote soft tissue regeneration and support healing in dental implant procedures.
subepithelial connective tissue graftProcedure or surgery
ubepithelial Connective Tissue Graft The subepithelial connective tissue graft is a biological tissue taken from the patient's own palate or other donor sites to promote healing and aesthetic outcomes around dental implants.
| Study group | Role | What they receive |
|---|---|---|
| Xenogeneic Collagen Matrix | Active comparator | This arm involves the use of a xenogeneic collagen matrix for soft tissue augmentation around early implant placement in the maxillary esthetic zone. Receives: Procedure: Xenogeneic Collagen Matrix |
| Subepithelial Connective Tissue Graft | Active comparator | This arm involves the use of a subepithelial connective tissue graft for soft tissue augmentation around early implant placement in the maxillary esthetic zone. Receives: Procedure: subepithelial 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
change in soft tissue thickness measured in millimeters at the buccal aspect of the implant site.
Measured: 12 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start17 Mar 2022
- Primary completion8 Nov 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Minia 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
- Model description
- Participants are assigned in parallel to either the xenogeneic collagen matrix group or the subepithelial connective tissue graft group for soft tissue augmentation around early implant placement in the maxillary esthetic zone. Group allocation is determined by simple randomization using a coin toss.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar ismail phd, Minia University
- Investigators
- Mohamed O Ismail, MSc, Principal investigator, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024186
- Sponsor's protocol ID
- Study ID: 505-2021
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Augmentation by Xenogenic Collagen Matrix Versus Sub Epithelial Connective Tissue Graft Around Early Implant Placement in Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT07024186
- Acronym / sponsor ID
- Study ID: 505-2021
- Keywords
- Xenogenic Collagen Matrix, Connective Tissue Graft, Soft Tissue Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 17 Jun 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.
This study compares two methods used to improve gingival tissue around dental implants placed in (the maxillary esthetic zone). After a tooth is removed and a dental implant is placed early (usually 4-8 weeks later), additional soft tissue is sometimes needed to ensure the implant looks natural and functions well. The two techniques being studied are:
Subepithelial connective tissue graft (SCTG) - where tissue is taken from the patient's own mouth (usually the palate)
Xenogeneic collagen matrix (XCM) - a processed collagen material from animals, used as a substitute for the patient's own tissue.
The goal is to see which method is better in terms of gingival thickness, esthetic appearance, healing, and patient comfort. This research may help dentists choose the most effective and comfortable treatment for their patients.
Detailed description
Dental implants in the anterior maxillary region (esthetic zone) are commonly used to replace missing teeth. When implants are placed using the early placement protocol (typically 4-8 weeks after tooth extraction), additional soft tissue volume may be required to ensure an esthetically pleasing and functionally stable result.
Soft tissue augmentation can be achieved using:
Subepithelial connective tissue grafts (SCTG): A technique that involves harvesting tissue from the patient's own palate and placing it around the implant to improve gingival thickness and contour.
Xenogeneic collagen matrix (XCM): A biocompatible, animal-derived collagen scaffold designed to substitute for autologous tissue, reducing patient morbidity and surgical time.
This study is a prospective, randomized, controlled, parallel-arm clinical trial conducted at Minia University, Faculty of Dentistry. Eligible patients missing a single tooth in the anterior maxilla with a thin gingival biotype and requiring early implant placement were recruited. A total of 20 patients were randomly assigned into two groups (10 per group):
Group 1 (Control): Received subepithelial connective tissue graft harvested from the palate using the single-incision technique.
Group 2 (Test): Received xenogeneic collagen matrix (Mucoderm®) adapted and inserted into the grafting site.
Outcome Measures:
Primary Outcome:
Change in gingival thickness (GT) at 12 months post-surgery, measured via transgingival probing using a standardized protocol.
Secondary Outcomes:
Change in width of keratinized tissue (KTW)
Esthetic outcome (using clinical photographs and standardized scoring systems, e.g., Pink Esthetic Score)
Post-operative healing and complications
Patient-reported outcomes regarding comfort, pain, and satisfaction (using Visual Analog Scale questionnaires)
Clinical and radiographic assessments were performed at baseline, 6 months, and 12 months post-implant placement.
Ethical approval was obtained from the Research Ethics Committee of Minia University, and all participants provided informed consent. The study adheres to the Declaration of Helsinki and ICH-GCP guidelines.
This research aims to provide evidence on whether xenogeneic collagen matrix can serve as a viable, less invasive alternative to autogenous tissue grafts in implant dentistry, especially for cases with esthetic demand and thin soft tissue biotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned in parallel to either the xenogeneic collagen matrix group or the subepithelial connective tissue graft group for soft tissue augmentation around early implant placement in the maxillary esthetic zone. Group allocation is determined by simple randomization using a coin toss.
| Arm | Type | Receives |
|---|---|---|
| Xenogeneic Collagen Matrix | Active comparator | Procedure: Xenogeneic Collagen MatrixThis arm involves the use of a xenogeneic collagen matrix for soft tissue augmentation around early implant placement in the maxillary esthetic zone. |
| Subepithelial Connective Tissue Graft | Active comparator | Procedure: subepithelial connective tissue graftThis arm involves the use of a subepithelial connective tissue graft for soft tissue augmentation around early implant placement in the maxillary esthetic zone. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Non-restorable or hopeless teeth from maxillary anterior to first premolar due to one or more of the following:
- Extensive caries
- Root fractures
- Inability to perform functional crown lengthening due to gingival zenith line with high gingival display
- Improper crown-to-root ratio due to bone removal leading to aesthetic or restorative failure
Key exclusion criteria (6 listed)
- Pregnant women
- Smokers
- Presence of persistent chronic infection at the implant site
- Patients in the growth phase with partially erupted teeth
- Patients with parafunctional habits such as bruxism or clenching that may overload the implant
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 |
|---|---|---|
| Xenogeneic Collagen MatrixXenogeneic Collagen Matrix The xenogeneic collagen matrix is a biomaterial used to promote soft tissue regeneration and support healing in dental implant procedures. | Procedure or surgery | Xenogeneic Collagen Matrix |
| subepithelial connective tissue graftubepithelial Connective Tissue Graft The subepithelial connective tissue graft is a biological tissue taken from the patient's own palate or other donor sites to promote healing and aesthetic outcomes around dental implants. | Procedure or surgery | Subepithelial Connective Tissue Graft |
Primary outcome
Peri-implant soft tissue thickness
Time frame: 12 months after implant placement
change in soft tissue thickness measured in millimeters at the buccal aspect of the implant site.
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 17 Jun 2025.
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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.
Mohamed O Ismail, MSc principal investigator
Faculty of Dentistry, Minia 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 Xenogeneic Collagen Matrix and subepithelial connective tissue graft in people with Alveolar Bone Loss and Gingival Recession, run by Minia 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 8 inclusion and 6 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 17 Jun 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?
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?
Peri-implant soft tissue thickness (time frame: 12 months after implant placement). 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 17 Jun 2025.