Soft tissue defect Oral Health
Conditions
Interventions
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 im
Sponsors
Damascus University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Syria
Contacts
Public ContactAli Omair
Outcome results
None listed