Comparing collagen matrix and connective tissue grafts for improving smile aesthetics around dental implants
| ISRCTN | ISRCTN12208947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12208947 |
| ClinicalTrials.gov number | NCT06837688 |
- Submission date
- 06/11/2024
- Registration date
- 19/11/2024
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
One of the challenges in implant dentistry is to achieve optimal soft tissue esthetics (appearance) around implants in the anterior region (front of the mouth). Various techniques have been proposed to increase the thickness of the peri-implant soft tissue, such as using autogenous connective tissue grafts (CTGs) or xenogenic collagen matrices (XCMs). However, there is a lack of evidence on the comparative effectiveness and patient satisfaction of these two methods. Therefore, the aim of this study is to compare the clinical and patient-reported outcomes of using CTG and XCM (Mucoderm®, Botiss Biomaterials, Germany) for simultaneous soft tissue augmentation around single implants in the esthetic zone.
Who can participate?
Adults aged 18 years or older who have a single missing tooth in the aesthetic zone of the maxilla (upper jaw).
What does the study involve?
The patients will be randomly assigned to one of the two intervention groups: the CTG group or the XCM group. Both groups will receive a single dental implant inserted with a guided implant surgery approach, the CTG group will simultaneously receive soft tissue augmentation using a tissue graft taken from their own palate, while the XCM group will simultaneously receive soft tissue augmentation using a xenogenic (animal) collagen matrix (Mucoderm®, Botiss Biomaterials, Germany). The implant surgery and soft tissue augmentation will be performed by a single experienced surgeon.
What are the possible benefits and risks of participating?
This study will determine the effectiveness of using XCM and CTG in soft tissue augmentation simultaneously with implant placement. There is a risk of not achieving optimal results in some cases but the study team can manage these cases with alternative methods.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
October 2024 to May 2026
Who is funding the study?
1. Damascus University (Syria)
2. Botiss Biomaterials
Who is the main contact?
Dr Ali Omair, ali.omair.formal@gmail.com
Contact information
Public, Scientific, Principal Investigator
Damascus
Damscus
00000
Syria
 ORCID ID |
0000-0002-5556-9830 |
|---|---|
| Phone | +963 (0)992964458 |
| ali.omair.formal@gmail.com |
Study information
| Study design | Comparative interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of xenogeneic collagen matrix versus subepithelial connective tissue graft to enhance soft tissue profile around single dental implants in the aesthetic zone |
| Study objectives | Is there a significant statistical difference between collagen matrix and connective tissue graft in terms of enhancing soft tissue profile around single dental implants. |
| Ethics approval(s) |
Not yet submitted, Damascus University Ethics Committee (Damascus, Damascus, 00000, Syria; Telephone number not provided; Email not provided), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Soft tissue defect |
| Intervention | The patients will be randomly assigned to one of the two intervention groups: connective tissue graft (CTG) group or xenogeneic collagen matrix (XCM) group. Both groups will receive a single dental implant inserted with a guided implant surgery approach, the CTG group will simultaneously receive soft tissue augmentation using an autogenous connective tissue graft harvested from the palate, while the XCM group will simultaneously receive soft tissue augmentation using a xenogenic collagen matrix (Mucoderm®, Botiss Biomaterials, Germany). The randomization will be performed by a computer-generated random number sequence. The implant surgery and soft tissue augmentation will be performed by a single experienced surgeon. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Changes in buccal soft tissue volume: an intra-oral scan will be used to analyze volumetric and profilometric changes of the buccal soft tissue at the following time points in each patient: T0 (pre-op), T1 (immediately post-op), and T2 (at 3 months). The intra-oral scan data will be processed and compared using a specific software to calculate the difference in soft tissue volume between the groups and the time points. 2. Patient-reported outcome measures: postoperative bleeding, pain, oedema, and hematoma will be assessed using a visual analogue scale (VAS) 1 week following surgery. Furthermore, the willingness of the patient to undergo the same treatment again, and the patients’ aesthetic satisfaction will be assessed using a Likert scale at 3 months. 3. Aesthetic outcomes: such as mid-facial recession, pink aesthetic score, and mucosal scarring index will be evaluated at 3 months and 6 months. The mid-facial recession will be measured as the distance from the middle point of the incisal edge of the implant-supported crown to the mucosal margin. The pink aesthetic score (PES) will be used to assess the harmony of the peri-implant soft tissue with the adjacent teeth and gingiva, based on seven criteria: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and soft tissue texture. The mucosal scarring index (MSI) will be used to assess the presence and severity of scar formation at the graft site, based on four criteria: color, contour, texture, and vascularity. |
| Secondary outcome measures | 1. Clinical outcomes: such as graft dimensions, wound closure, surgery time, and complications will be recorded by the surgeon during and after the surgery. The graft dimensions will include the length, width, and thickness of the graft before and after the placement. The surgery time will be measured from the start of the incision to the end of the suturing. The complications will include any adverse events such as infection, dehiscence, necrosis, or loss of the graft or the implant. 2. Peri-implant health parameters: such as marginal bone loss, probing depth, plaque, and bleeding on probing will be measured at the implant site at baseline, 3 months, and 6 months. The marginal bone loss will be measured on the CBCT images as the distance from the implant shoulder to the first bone-to-implant contact. The probing depth will be measured using a periodontal probe at six sites around the implant. The plaque and bleeding on probing will be assessed using the modified plaque index (mPI) and the modified bleeding index (mBI), respectively. |
| Overall study start date | 01/10/2024 |
| Completion date | 01/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patient is older than 18 years old 2. Patient has excellent oral hygiene; less than 25% according to O'Leary index 3. Patient has a single missing tooth in the aesthetic zone of the maxilla 4. Failing tooth removed at least 3 months prior to enrolment 5. At least 5 mm of keratinized mucosa available at the single tooth gap 6. Bucco-palatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap as assessed on cone beam computed tomography (CBCT) to ensure complete embedding of an implant by bone |
| Key exclusion criteria | 1. Systemic diseases 2. Smoking 3. Periodontal disease 4. Need for horizontal bone augmentation at the time of implant placement 5. Patient previously underwent soft or hard tissue augmentation at the site of the procedure |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 01/08/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
00000
Syria
Sponsor information
University/education
Damascus
Damascus
00000
Syria
| Phone | +963 (0)113341864 |
|---|---|
| manager@hcsr.gov.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
No information available
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication of the research results |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Dr Ali Omair (ali.omair.formal@gmail.com) and in the publication related to it after the end of the research. |
Editorial Notes
04/03/2025: ClincalTrials.gov number added.
07/11/2024: Study's existence confirmed by Damascus University.
