Missing TeethNCT06837688
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
A study testing Peri-implant soft tissue augmentation using connective tissue graft and Peri-implant soft tissue augmentation using xenogenic collagen matrix in people with Missing Teeth, run by Damascus University at 1 site in Syria.
Trial summary
This randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Peri-implant soft tissue augmentation using connective tissue graft and Peri-implant soft tissue augmentation using xenogenic collagen matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 1 Mar 2025to 31 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 years or older.
- Good oral hygiene, defined as full-mouth plaque score ≤25%.
- Having a single missing tooth in the aesthetic zone of the maxilla.
- Tooth extraction occurred at least 3 months prior to enrolment.
- Having adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm).
- Having at least 5 mm of keratinized tissue width at the implant site.
Who cannot join
- Systemic diseases.
- Smoking.
- Periodontal disease.
- Untreated caries lesions.
- Need for horizontal bone augmentation at the time of implant placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Xenogeneic Collagen Matrix Versus Connective Tissue Graft to Enhance Soft Tissue Profile Around Single Dental Implants in the Aesthetic Zone
This randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Thirty adult patients with a single missing tooth, adequate bone volume, and sufficient keratinized tissue will be recruited at Damascus University. Each patient will undergo a fully digital workflow for implant planning-including CBCT imaging, intraoral scanning, and CAD/CAM fabrication of a surgical guide and provisional restoration-to ensure precision in implant placement. Immediately following implant insertion, patients will be randomly allocated (1:1) to either receive a CTG harvested from the palatal mucosa using a single incision technique or an XCM (Mucoderm®, Botiss Biomaterials) that is adapted and secured to the buccal mucosa. The primary outcome is the increase in buccal soft tissue profile, measured via superimposed digital surface models at baseline, immediately postoperatively, and at 3 months. Secondary outcomes include patient-reported measures (pain, edema, aesthetic satisfaction), clinical parameters (keratinized tissue width, soft tissue height), peri-implant health assessments, and radiographic assessment. By comparing these two methods, the study aims to determine whether the less invasive XCM can offer outcomes comparable to the CTG standard while reducing donor site morbidity and overall surgical time.
Read the detailed description
This clinical trial is designed to evaluate and compare the performance of two soft tissue augmentation techniques-autogenous subepithelial connective tissue graft (CTG) and xenogeneic collagen matrix (XCM, Mucoderm®)-when used concurrently with dental implant placement in the aesthetic zone of the anterior maxilla. The rationale for this study stems from the clinical challenge of achieving optimal soft tissue esthetics and function following tooth loss. While CTG has long been considered the gold standard for increasing peri-implant soft tissue thickness, it requires a secondary surgical site, which may lead to donor site morbidity, limited tissue availability, and increased surgical time. In contrast, XCM offers a promising alternative that is biocompatible, readily available, and less invasive.
Patients aged 18 years or older with a single missing tooth in the aesthetic zone, adequate bucco-palatal bone (≥6 mm), and at least 5 mm of keratinized tissue width will be considered eligible for the study. The enrollment process begins with a thorough screening process involving clinical and radiographic examinations, including a low-dose, small-field CBCT scan and an intraoral scan. These imaging modalities allow for accurate digital implant planning using specialized software, ensuring optimal implant positioning. The digital data will be used to fabricate a stereolithographic surgical guide and design a custom CAD/CAM screw-retained provisional restoration.
Following successful screening and informed consent, the surgical phase commences. Under local anesthesia, a full-thickness flap is elevated at the implant site. Guided by the digital plan, a dental implant is precisely positioned using the surgical guide. At this point, participants are allocated to one of two intervention groups based on a strict randomization protocol.
In the CTG group, a connective tissue graft is harvested from the palatal mucosa using the de- epithelialized free gingival graft technique. The harvested graft is then trimmed to match the dimensions of the recipient site and carefully positioned under the elevated flap to augment the soft tissue. The donor site is sutured using gelatin matrix to ensure proper healing. This technique, while effective, is associated with postoperative discomfort and additional surgical time due to the need for a second operative site.
Conversely, in the XCM group, soft tissue augmentation is achieved using a xenogeneic collagen matrix (Mucoderm®). The graft, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. Following soft tissue augmentation, a screw-retained provisional restoration is attached immediately, contributing to both function and esthetics during the healing phase.
The primary outcome of the study is the increase in the buccal soft tissue profile, quantitatively assessed using intraoral scans to generate digital surface models at three critical time points: preoperatively (T0), immediately after surgery (T1), and 3 months postoperatively (T2). Secondary outcomes include clinical assessments-such as probing depth, plaque index, bleeding on probing, keratinized tissue width, graft dimensions, wound closure, surgery time, and complications-as well as radiographic evaluation of marginal bone loss. In addition, patient-reported outcome measures (PROMs), including postoperative pain, swelling, aesthetic satisfaction, and willingness to undergo the same treatment again, will be recorded using validated visual analogue and Likert scales. Aesthetic outcomes, including mid-facial recession, Pink aesthetic score, and mucosal scarring index, will also be documented.
The data will be analyzed on an intention-to-treat basis by an independent statistician. Statistical comparisons between the two groups will help determine whether the xenogeneic collagen matrix offers comparable or superior results to the autogenous connective tissue graft regarding soft tissue volume augmentation, esthetic outcomes, and patient satisfaction. Ethical approval has been obtained from the University of Damascus, and the trial follows the CONSORT guidelines. The results will be disseminated through peer-reviewed publications and presentations at professional conferences, contributing valuable evidence to the field of implant dentistry.
Overall, this study is expected to provide insight into whether XCM can serve as a reliable, less invasive alternative to CTG, thereby potentially enhancing patient outcomes and reducing the complications associated with donor site morbidity.
- Conditions
- Missing Teeth
- Being tested
- Peri-implant soft tissue augmentation using connective tissue graft, Peri-implant soft tissue augmentation using xenogenic collagen matrix
- Keywords
- Peri-implant soft tissue augmentation, Xenogeneic collagen matrix, Connective tissue graft
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-implant soft tissue augmentation using connective tissue graftProcedure or surgery
A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. A connective tissue graft (CTG) will be harvested from the palatal mucosa using the De-epithelialized free gingival graft technique and tailored to the site dimensions. The graft will be carefully positioned under the elevated flap to augment the soft tissue. The palatal wound will be sutured with double-cross sutures.
Peri-implant soft tissue augmentation using xenogenic collagen matrixProcedure or surgery
A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. The xenogenic collagen matrix, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft group | Active comparator | Patients receive soft tissue augmentation using an autogenous connective tissue graft. A full-thickness flap is elevated at the implant site, and after implant placement, a CTG is harvested from the palatal mucosa. The graft is then trimmed to the defect dimensions and positioned under the flap to augment the peri-implant soft tissue. The donor site is sutured with double-cross sutures to ensure proper healing Receives: Procedure: Peri-implant soft tissue augmentation using connective tissue graft |
| Xenogeneic collagen matrix group | Experimental | Patients receive soft tissue augmentation using a xenogeneic collagen matrix (Mucoderm®). After implant placement and flap elevation, the XCM, initially sized at 15 × 20 mm, is moistened in saline for 10 minutes and slightly compressed. It is then adapted to the recipient site following a superficial incision to release muscle tension and secured to the buccal mucosa with single sutures. A screw-retained provisional restoration is installed immediately after surgery to support the augmented tissue. Receives: Procedure: Peri-implant soft tissue augmentation using xenogenic collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Buccal Soft Tissue Profile (BSP)
he BSP is defined as the volumetric change in the buccal soft tissue at the dental implant site. This outcome reflects both the thickness and contour improvements following soft tissue augmentation. Intraoral scans will be taken at three critical time points: preoperatively (T0), immediately postoperatively (T1), and 3 months postoperatively (T2). Digital surface models will be generated from these scans using specialized analysis software. The increase in BSP will be quantified as the difference in soft tissue volume (or thickness, depending on the analysis protocol) between the baseline (T0) and the 3-month follow-up (T2). Graft shrinkage will be measured between the scans immediately postoperatively (T1) and the 3-month follow-up (T2). his is a continuous variable measured in cubic millimeters (mm³) if volumetric data is used, or in millimeters (mm) if linear thickness is the chosen metric.
Measured: T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively
Secondary outcomes (14)
Probing Depth (PD)
- Definition: The distance from the gingival margin to the bottom of the peri-implant pocket measured around the implant.
- Measurement: Using a UNC-15 periodontal probe at six sites around the implant.
- Type: Continuous variable (measured in millimeters).
Measured: Baseline (Preoperative), 3 months, and 6 months postoperatively
Plaque Index (PI)
- Definition: An ordinal score representing the level of plaque accumulation around the implant.
- Measurement: Using a standardized modified plaque index (mPI).
- Type: Ordinal variable.
Measured: Baseline (Preoperative), 3 months, and 6 months postoperatively.
Bleeding on Probing (BOP)
- Definition: The presence or absence of bleeding upon gentle probing, indicating inflammation.
- Measurement: Using a standardized modified bleeding index (mBI).
- Type: Binary at each site, then aggregated.
Measured: Baseline (Preoperative), 3 months, and 6 months postoperatively
Graft Dimensions
- Definition: The length, width, and thickness of the graft as applied.
- Measurement: Recorded intraoperatively using a UNC-15 periodontal probe.
- Type: Continuous variables (in millimeters).
Measured: Recorded intraoperatively.
Wound Closure
- Definition: Wound closure is evaluated qualitatively (complete vs. incomplete).
- Measurement: Wound closure is documented by the surgeon.
- Type: Wound closure is categorical.
Measured: Recorded intraoperatively.
Surgery Time
- Definition: Surgery time is the duration from the initial incision to the final suture placement.
- Measurement: Surgery time is measured with a stopwatch.
- Type: Surgery time is a continuous variable (in minutes).
Measured: immediately following surgery
Complications
- Definition: Any adverse events such as infection, dehiscence, graft or implant loss.
- Measurement: Documented by the surgical team and followed up clinically.
- Type: Categorical (present/absent, with descriptive details).
Measured: From intervention to the end of follow-up period at 6 months.
Radiographic Evaluation of Marginal Bone Loss
- Definition: The change in bone level around the implant measured from the implant shoulder to the first bone-to-implant contact.
- Measurement: Using CBCT images.
- Type: Continuous variable (in millimeters).
Measured: Baseline (immediately postoperative), and 6 months postoperatively.
Postoperative Pain and Swelling
- Definition: Patient's subjective rating of pain and swelling after surgery.
- Measurement: Using a visual analogue scale (VAS) ranging from 0 (no pain/swelling) to 10 (worst possible pain/swelling).
- Type: Ordinal variable.
Measured: One week postoperatively.
Aesthetic Satisfaction
- Definition: Patient's satisfaction with the aesthetic outcome of the implant restoration and surrounding soft tissue.
- Measurement: Using a Likert scale (1-5, where 1 is very dissatisfied and 5 is very satisfied).
- Type: Ordinal variable.
Measured: 3 months postoperatively.
Willingness to Undergo the Same Treatment Again
- Definition: Patient's acceptance and perceived comfort of the treatment procedure.
- Measurement: Assessed via a Likert scale (1-5, from not willing to very willing).
- Type: Ordinal variable.
Measured: 3 months postoperatively.
Mid-Facial Recession
- Definition: The vertical distance from the incisal edge of the implant-supported crown to the level of the buccal mucosal margin.
- Measurement: Using a periodontal probe.
- Type: Continuous variable (in millimeters).
Measured: 3 and 6 months postoperatively.
Pink Aesthetic Score (PES)
- Definition: A composite score evaluating the harmony of the peri-implant soft tissue with adjacent teeth, based on criteria such as mesial/distal papilla, tissue level, contour, and color.
- Measurement: Using a standardized scoring system (0-14 scale).
- Type: Ordinal variable.
Measured: 3 and 6 months postoperatively.
Mucosal Scarring Index (MSI)
- Definition: A measure of the presence and severity of scar formation at the graft site, based on criteria like color, contour, texture, and vascularity.
- Measurement: Assessed using a categorical scoring system.
- Type: Categorical variable.
Measured: 3 and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suleiman Dayoub, DDS MSc PhD, Study director, Damarcus UniversityAli Omair, DDS, Principal investigator, Damarcus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837688
- Sponsor's protocol ID
- UDDS-Perio-01-2025
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tommasato G, Del Fabbro M, Oliva N, Khijmatgar S, Grusovin MG, Sculean A, Canullo L. Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis. Clin Oral Investig. 2024 May 5;28(5):300. doi: 10.1007/s00784-024-05684-5.
PubMed 38704784Dadlani S, Joseph B, Anil S. Efficacy of Xenogeneic Collagen Matrices in Augmenting Peri-Implant Soft Tissue: A Systematic Review and Meta-Analysis. Clin Exp Dent Res. 2024 Aug;10(4):e937. doi: 10.1002/cre2.937.
PubMed 39104130Hamdy A, Ibrahim SSA, Ghalwash D, Adel-Khattab D. Volumetric assessment of volume stable collagen matrix in maxillary single implant site development: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2024 Oct;26(5):930-941. doi: 10.1111/cid.13353. Epub 2024 Jun 27.
PubMed 38938060Surdiacourt L, Christiaens V, De Bruyckere T, De Buyser S, Eghbali A, Vervaeke S, Younes F, Cosyn J. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-Year results. J Clin Periodontol. 2025 Jan;52(1):92-101. doi: 10.1111/jcpe.13975. Epub 2024 Mar 14.
PubMed 38485651Eeckhout C, Vuylsteke F, Seyssens L, Christiaens V, De Bruyckere T, Eghbali A, Vervaeke S, Younes F, Cosyn J. A Multi-Centre Randomized Controlled Trial Comparing Connective Tissue Graft with Collagen Matrix to Increase Buccal Soft Tissue Thickness: A Cone-Beam CT Analysis. J Clin Med. 2023 Apr 19;12(8):2977. doi: 10.3390/jcm12082977.
PubMed 37109311Cosyn J, Eeckhout C, Christiaens V, Eghbali A, Vervaeke S, Younes F, De Bruyckere T. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-month results. J Clin Periodontol. 2021 Dec;48(12):1502-1515. doi: 10.1111/jcpe.13560. Epub 2021 Oct 12.
PubMed 34605057
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Xenogeneic Collagen Matrix Versus Connective Tissue Graft to Enhance Soft Tissue Profile Around Single Dental Implants in the Aesthetic Zone
- ClinicalTrials.gov ID
- NCT06837688
- Acronym / sponsor ID
- UDDS-Perio-01-2025
- Conditions
- Missing Teeth
- Keywords
- Peri-implant soft tissue augmentation, Xenogeneic collagen matrix, Connective tissue graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 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 randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Thirty adult patients with a single missing tooth, adequate bone volume, and sufficient keratinized tissue will be recruited at Damascus University. Each patient will undergo a fully digital workflow for implant planning-including CBCT imaging, intraoral scanning, and CAD/CAM fabrication of a surgical guide and provisional restoration-to ensure precision in implant placement. Immediately following implant insertion, patients will be randomly allocated (1:1) to either receive a CTG harvested from the palatal mucosa using a single incision technique or an XCM (Mucoderm®, Botiss Biomaterials) that is adapted and secured to the buccal mucosa. The primary outcome is the increase in buccal soft tissue profile, measured via superimposed digital surface models at baseline, immediately postoperatively, and at 3 months. Secondary outcomes include patient-reported measures (pain, edema, aesthetic satisfaction), clinical parameters (keratinized tissue width, soft tissue height), peri-implant health assessments, and radiographic assessment. By comparing these two methods, the study aims to determine whether the less invasive XCM can offer outcomes comparable to the CTG standard while reducing donor site morbidity and overall surgical time.
Detailed description
This clinical trial is designed to evaluate and compare the performance of two soft tissue augmentation techniques-autogenous subepithelial connective tissue graft (CTG) and xenogeneic collagen matrix (XCM, Mucoderm®)-when used concurrently with dental implant placement in the aesthetic zone of the anterior maxilla. The rationale for this study stems from the clinical challenge of achieving optimal soft tissue esthetics and function following tooth loss. While CTG has long been considered the gold standard for increasing peri-implant soft tissue thickness, it requires a secondary surgical site, which may lead to donor site morbidity, limited tissue availability, and increased surgical time. In contrast, XCM offers a promising alternative that is biocompatible, readily available, and less invasive.
Patients aged 18 years or older with a single missing tooth in the aesthetic zone, adequate bucco-palatal bone (≥6 mm), and at least 5 mm of keratinized tissue width will be considered eligible for the study. The enrollment process begins with a thorough screening process involving clinical and radiographic examinations, including a low-dose, small-field CBCT scan and an intraoral scan. These imaging modalities allow for accurate digital implant planning using specialized software, ensuring optimal implant positioning. The digital data will be used to fabricate a stereolithographic surgical guide and design a custom CAD/CAM screw-retained provisional restoration.
Following successful screening and informed consent, the surgical phase commences. Under local anesthesia, a full-thickness flap is elevated at the implant site. Guided by the digital plan, a dental implant is precisely positioned using the surgical guide. At this point, participants are allocated to one of two intervention groups based on a strict randomization protocol.
In the CTG group, a connective tissue graft is harvested from the palatal mucosa using the de- epithelialized free gingival graft technique. The harvested graft is then trimmed to match the dimensions of the recipient site and carefully positioned under the elevated flap to augment the soft tissue. The donor site is sutured using gelatin matrix to ensure proper healing. This technique, while effective, is associated with postoperative discomfort and additional surgical time due to the need for a second operative site.
Conversely, in the XCM group, soft tissue augmentation is achieved using a xenogeneic collagen matrix (Mucoderm®). The graft, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. Following soft tissue augmentation, a screw-retained provisional restoration is attached immediately, contributing to both function and esthetics during the healing phase.
The primary outcome of the study is the increase in the buccal soft tissue profile, quantitatively assessed using intraoral scans to generate digital surface models at three critical time points: preoperatively (T0), immediately after surgery (T1), and 3 months postoperatively (T2). Secondary outcomes include clinical assessments-such as probing depth, plaque index, bleeding on probing, keratinized tissue width, graft dimensions, wound closure, surgery time, and complications-as well as radiographic evaluation of marginal bone loss. In addition, patient-reported outcome measures (PROMs), including postoperative pain, swelling, aesthetic satisfaction, and willingness to undergo the same treatment again, will be recorded using validated visual analogue and Likert scales. Aesthetic outcomes, including mid-facial recession, Pink aesthetic score, and mucosal scarring index, will also be documented.
The data will be analyzed on an intention-to-treat basis by an independent statistician. Statistical comparisons between the two groups will help determine whether the xenogeneic collagen matrix offers comparable or superior results to the autogenous connective tissue graft regarding soft tissue volume augmentation, esthetic outcomes, and patient satisfaction. Ethical approval has been obtained from the University of Damascus, and the trial follows the CONSORT guidelines. The results will be disseminated through peer-reviewed publications and presentations at professional conferences, contributing valuable evidence to the field of implant dentistry.
Overall, this study is expected to provide insight into whether XCM can serve as a reliable, less invasive alternative to CTG, thereby potentially enhancing patient outcomes and reducing the complications associated with donor site morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft group | Active comparator | Procedure: Peri-implant soft tissue augmentation using connective tissue graftPatients receive soft tissue augmentation using an autogenous connective tissue graft. A full-thickness flap is elevated at the implant site, and after implant placement, a CTG is harvested from the palatal mucosa. The graft is then trimmed to the defect dimensions and positioned under the flap to augment the peri-implant soft tissue. The donor site is sutured with double-cross sutures to ensure proper healing |
| Xenogeneic collagen matrix group | Experimental | Procedure: Peri-implant soft tissue augmentation using xenogenic collagen matrixPatients receive soft tissue augmentation using a xenogeneic collagen matrix (Mucoderm®). After implant placement and flap elevation, the XCM, initially sized at 15 × 20 mm, is moistened in saline for 10 minutes and slightly compressed. It is then adapted to the recipient site following a superficial incision to release muscle tension and secured to the buccal mucosa with single sutures. A screw-retained provisional restoration is installed immediately after surgery to support the augmented tissue. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- Good oral hygiene, defined as full-mouth plaque score ≤25%.
- Having a single missing tooth in the aesthetic zone of the maxilla.
- Tooth extraction occurred at least 3 months prior to enrolment.
- Having adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm).
Key exclusion criteria (5 listed)
- Systemic diseases.
- Smoking.
- Periodontal disease.
- Untreated caries lesions.
- Need for horizontal bone augmentation at the time of implant placement.
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 |
|---|---|---|
| Peri-implant soft tissue augmentation using connective tissue graftA full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. A connective tissue graft (CTG) will be harvested from the palatal mucosa using the De-epithelialized free gingival graft technique and tailored to the site dimensions. The graft will be carefully positioned under the elevated flap to augment the soft tissue. The palatal wound will be sutured with double-cross sutures. | Procedure or surgery | Connective tissue graft group |
| Peri-implant soft tissue augmentation using xenogenic collagen matrixA full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. The xenogenic collagen matrix, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. | Procedure or surgery | Xenogeneic collagen matrix group |
Primary outcome
Increase in Buccal Soft Tissue Profile (BSP)
Time frame: T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively
he BSP is defined as the volumetric change in the buccal soft tissue at the dental implant site. This outcome reflects both the thickness and contour improvements following soft tissue augmentation. Intraoral scans will be taken at three critical time points: preoperatively (T0), immediately postoperatively (T1), and 3 months postoperatively (T2). Digital surface models will be generated from these scans using specialized analysis software. The increase in BSP will be quantified as the difference in soft tissue volume (or thickness, depending on the analysis protocol) between the baseline (T0) and the 3-month follow-up (T2). Graft shrinkage will be measured between the scans immediately postoperatively (T1) and the 3-month follow-up (T2). his is a continuous variable measured in cubic millimeters (mm³) if volumetric data is used, or in millimeters (mm) if linear thickness is the chosen metric.
14 secondary outcomes
Probing Depth (PD)
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively
Plaque Index (PI)
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively.
Bleeding on Probing (BOP)
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively
Graft Dimensions
Time frame: Recorded intraoperatively.
Wound Closure
Time frame: Recorded intraoperatively.
Surgery Time
Time frame: immediately following surgery
Complications
Time frame: From intervention to the end of follow-up period at 6 months.
Radiographic Evaluation of Marginal Bone Loss
Time frame: Baseline (immediately postoperative), and 6 months postoperatively.
Postoperative Pain and Swelling
Time frame: One week postoperatively.
Aesthetic Satisfaction
Time frame: 3 months postoperatively.
Willingness to Undergo the Same Treatment Again
Time frame: 3 months postoperatively.
Mid-Facial Recession
Time frame: 3 and 6 months postoperatively.
Pink Aesthetic Score (PES)
Time frame: 3 and 6 months postoperatively.
Mucosal Scarring Index (MSI)
Time frame: 3 and 6 months postoperatively.
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 1 Sep 2026.
- Background: PubMed 38704784Tommasato G, Del Fabbro M, Oliva N, Khijmatgar S, Grusovin MG, Sculean A, Canullo L. Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis. Clin Oral Investig. 2024 May 5;28(5):300. doi: 10.1007/s00784-024-05684-5.
- Background: PubMed 39104130Dadlani S, Joseph B, Anil S. Efficacy of Xenogeneic Collagen Matrices in Augmenting Peri-Implant Soft Tissue: A Systematic Review and Meta-Analysis. Clin Exp Dent Res. 2024 Aug;10(4):e937. doi: 10.1002/cre2.937.
- Background: PubMed 38938060Hamdy A, Ibrahim SSA, Ghalwash D, Adel-Khattab D. Volumetric assessment of volume stable collagen matrix in maxillary single implant site development: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2024 Oct;26(5):930-941. doi: 10.1111/cid.13353. Epub 2024 Jun 27.
- Background: PubMed 38485651Surdiacourt L, Christiaens V, De Bruyckere T, De Buyser S, Eghbali A, Vervaeke S, Younes F, Cosyn J. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-Year results. J Clin Periodontol. 2025 Jan;52(1):92-101. doi: 10.1111/jcpe.13975. Epub 2024 Mar 14.
- Background: PubMed 37109311Eeckhout C, Vuylsteke F, Seyssens L, Christiaens V, De Bruyckere T, Eghbali A, Vervaeke S, Younes F, Cosyn J. A Multi-Centre Randomized Controlled Trial Comparing Connective Tissue Graft with Collagen Matrix to Increase Buccal Soft Tissue Thickness: A Cone-Beam CT Analysis. J Clin Med. 2023 Apr 19;12(8):2977. doi: 10.3390/jcm12082977.
- Background: PubMed 34605057Cosyn J, Eeckhout C, Christiaens V, Eghbali A, Vervaeke S, Younes F, De Bruyckere T. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-month results. J Clin Periodontol. 2021 Dec;48(12):1502-1515. doi: 10.1111/jcpe.13560. Epub 2021 Oct 12.
- 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.
Suleiman Dayoub, DDS MSc PhD study director
Damarcus University
Ali Omair, DDS principal investigator
Damarcus 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 Peri-implant soft tissue augmentation using connective tissue graft and Peri-implant soft tissue augmentation using xenogenic collagen matrix in people with Missing Teeth, run by Damascus University at 1 site in Syria.
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 1 Sep 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 Syria. 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?
Increase in Buccal Soft Tissue Profile (BSP) (time frame: T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively). 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 NCT06837688, which also lists 6 linked publications.
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 1 Sep 2026.