DentalNCT06808243
Modified Periosteal Tissue Graft vs Collagen Matrix for Soft Tissue Augmentation Around Implants: A Comparative Study
A study testing connective tissue graft and xenogenic collagen membrane in people with Dental and Implant, run by Minia University at 1 site in Egypt.
Trial summary
This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . Read more about this study
- Who is it for?
- Ages 20 to 40 years
- What is being tested?
- connective tissue graft and xenogenic collagen membrane
- Type of treatment
- Medical device, 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 Jan 2024to 30 Dec 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy
- teeth indicated for extraction due to trauma or root fracture
- periodontally healthy
- Good oral health
- Selected patients of both sexes are 20-40 years old.
Who cannot join
- parafunctional habits
- smoking, alcoholism
- pregnancy
- lactation
- untreated periodontal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Vascularized Interpostional Periosteal Connective Tissue Graft Versus Xenogeneic Collagen Matrix for Soft Tissue Augmentation Around Implant in Esthetic Zone (Comparative Study)
This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation
Read the detailed description
This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.
The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.
The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.
- Being tested
- connective tissue graft, xenogenic collagen membrane
- Keywords
- implant, connective tissue graft, xenogenic membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
10 patients received mVIP-CTG
xenogenic collagen membraneDevice
10 patients received XCM
| Study group | Role | What they receive |
|---|---|---|
| modified vestibular interpositional periosteal connective tissue graft | Experimental | 10 patients received pedicled CTG (mVIP-CTG) Receives: Procedure: connective tissue graft |
| Xenogenic Collagen Membrane | Experimental | 10 patients received xenogenic collagen membrane Receives: Device: xenogenic collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratinized tissue thickness
measurement of Kertinized tissue thickness around implant using endodontic file
Measured: baseline, 3 months, 6 months
keratinized tissue width
measurement of keratinized tissue width using graduated UNC-15 Probe
Measured: baseline, 3 months and 6 months
buccal cortex thickness
measurement of buccal cortex thickness using CBCT
Measured: baseline and 6 months
Secondary outcomes (1)
pink esthetic score
measurement of pink aesthetic using visual scale of pink asethetic score
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelmaged, Minia University
- Investigators
- Heba Ah Abdel-maged, MSc, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808243
- Sponsor's protocol ID
- 543/84/2021
- Other IDs
- clinical trial
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Abdelmaged HA, Moustafa AA, Khalil AA. Modified vascularized interpositional periosteal connective tissue graft versus xenogeneic collagen matrix for soft tissue augmentation around implant in esthetic zone (A comparative Study). BMC Oral Health. 2025 Dec 12;25(1):1932. doi: 10.1186/s12903-025-07345-9.
PubMed 41382211
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Vascularized Interpostional Periosteal Connective Tissue Graft Versus Xenogeneic Collagen Matrix for Soft Tissue Augmentation Around Implant in Esthetic Zone (Comparative Study)
- ClinicalTrials.gov ID
- NCT06808243
- Acronym / sponsor ID
- 543/84/2021
- Keywords
- implant, connective tissue graft, xenogenic membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Feb 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 clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation
Detailed description
This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.
The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.
The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified vestibular interpositional periosteal connective tissue graft | Experimental | Procedure: connective tissue graft10 patients received pedicled CTG (mVIP-CTG) |
| Xenogenic Collagen Membrane | Experimental | Device: xenogenic collagen membrane10 patients received xenogenic collagen membrane |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- systemically healthy
- teeth indicated for extraction due to trauma or root fracture
- periodontally healthy
- Good oral health
- Selected patients of both sexes are 20-40 years old.
Key exclusion criteria (5 listed)
- parafunctional habits
- smoking, alcoholism
- pregnancy
- lactation
- untreated periodontal diseases
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 |
|---|---|---|
| connective tissue graft10 patients received mVIP-CTG | Procedure or surgery | modified vestibular interpositional periosteal connective tissue graft |
| xenogenic collagen membrane10 patients received XCM | Device | Xenogenic Collagen Membrane |
Primary outcome
keratinized tissue thickness
Time frame: baseline, 3 months, 6 months
measurement of Kertinized tissue thickness around implant using endodontic file
keratinized tissue width
Time frame: baseline, 3 months and 6 months
measurement of keratinized tissue width using graduated UNC-15 Probe
buccal cortex thickness
Time frame: baseline and 6 months
measurement of buccal cortex thickness using CBCT
1 secondary outcome
pink esthetic score
Time frame: baseline and 6 months
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 5 Feb 2025.
- Derived from this study: PubMed 41382211Abdelmaged HA, Moustafa AA, Khalil AA. Modified vascularized interpositional periosteal connective tissue graft versus xenogeneic collagen matrix for soft tissue augmentation around implant in esthetic zone (A comparative Study). BMC Oral Health. 2025 Dec 12;25(1):1932. doi: 10.1186/s12903-025-07345-9.
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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.
Heba Ah Abdel-maged, MSc principal investigator
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 connective tissue graft and xenogenic collagen membrane in people with Dental and Implant, 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 5 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: finished, as of the sponsor's last update on 5 Feb 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?
keratinized tissue thickness (time frame: baseline, 3 months, 6 months). 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?
On the ClinicalTrials.gov record for NCT06808243, which also lists 1 linked publication.
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 5 Feb 2025.