Soft Tissue AtrophyNCT07577193
Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
A study testing All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II). in people with Soft Tissue Atrophy, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Soft Tissue Atrophy
- What is being tested?
- All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).
- 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
- 1 Oct 2025to 1 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient between 25-50 years old.
- Remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Inadequate keratinized soft tissue <2 mm (13).
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
Who cannot join
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry Mansoura university, Mansoura, 35516
Al Mansurah
About this study
Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.
Read the detailed description
Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.
- Conditions
- Soft Tissue Atrophy
- Being tested
- All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).Procedure or surgery
Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture.
Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture.
| Study group | Role | What they receive |
|---|---|---|
| dental implant with application of free gingival graft | Experimental | Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva Receives: Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II). |
| dental implants with application of porcine collagen matrix | Experimental | Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva. Receives: Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation:
Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection.
Unit: Yes/No. Time Frame: Post-operative follow-up visits.
Measured: 3 months
clinical
Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell).
Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months.
Measured: 3 months
Clinical
Surgical Operation Time: Duration of implant site preparation and graft fixation.
Unit: Minutes. Time Frame: During surgery.
Measured: 3 months
clinical
Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS).
Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively.
Measured: 3 months
Secondary outcomes (6)
Clinical periodontal parameters
Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index.
Unit: PI score. Time Frame: 3 months post-operatively.
Measured: 3 months
radiographic
- Implant Position Accuracy Description: Evaluation of the accuracy of dental implant placement in relation to adjacent teeth and surrounding vital anatomical structures using Cone Beam Computed Tomography (CBCT). Unit of Measure: Deviation distance in millimeters (mm) Time Frame: At 6 months post-implant placement
- Crestal Bone Level Changes - Mesiodistal Description: Measurement of crestal bone level changes in the mesiodistal direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement
- Crestal Bone Level Changes - Buccolingual
Description:
Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT.
Unit of Measure:
Millimeters (mm)
Time Frame:
At 6 months post-implant placement
Measured: 6 months
clinical parameters
Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health.
Unit: mm. Time Frame: 3 months post-operatively.
Measured: 3 months
clinical perodontal parameters
Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket.
Unit: mm. Time Frame: 3 months post-operatively.
Measured: 3 months
clinical periodontal parameters
Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site.
Unit: mm. Time Frame: 3 months post-operatively.
Measured: 3 months
clinical periodontal parameters
Gingival Thickness (GT): Thickness of peri-implant gingiva. Unit: mm. Time Frame: 3 months post-operatively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Oct 2025
- Primary completion28 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AtrophyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- surgery and give medication
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamad sa haichal, bachelor, Principal investigator, faculty of dentistry Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577193
- Sponsor's protocol ID
- A0101025 OM
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
- ClinicalTrials.gov ID
- NCT07577193
- Acronym / sponsor ID
- A0101025 OM
- Conditions
- Soft Tissue Atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 May 2026 (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 The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.
Detailed description
Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- surgery and give medication
| Arm | Type | Receives |
|---|---|---|
| dental implant with application of free gingival graft | Experimental | Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva |
| dental implants with application of porcine collagen matrix | Experimental | Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient between 25-50 years old.
- Remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Inadequate keratinized soft tissue <2 mm (13).
- Favorable pattern of occlusion.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
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 |
|---|---|---|
| All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture. | Procedure or surgery | dental implant with application of free gingival graft, dental implants with application of porcine collagen matrix |
Primary outcome
Clinical Evaluation:
Time frame: 3 months
Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits.
clinical
Time frame: 3 months
Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months.
Clinical
Time frame: 3 months
Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery.
clinical
Time frame: 3 months
Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS). Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively.
6 secondary outcomes
Clinical periodontal parameters
Time frame: 3 months
radiographic
Time frame: 6 months
clinical parameters
Time frame: 3 months
clinical perodontal parameters
Time frame: 3 months
clinical periodontal parameters
Time frame: 3 months
clinical periodontal parameters
Time frame: 3 months
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 11 May 2026.
- Individual participant dataSharing planned: No
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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.
mohamad sa haichal, bachelor principal investigator
faculty of dentistry Mansoura 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 All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II). in people with Soft Tissue Atrophy, run by Mansoura 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 6 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
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?
Clinical Evaluation: (time frame: 3 months). The study lists 4 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 11 May 2026.