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This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery.
Clinical, radiographic, and digital assessment methods will be used to investigate the early effects of these grafts on peri-implant mucosal width and thickness. In addition, peri-implant tissue health and patient-reported outcomes will be evaluated to compare the effectiveness of the grafting techniques in peri-implant soft tissue management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronal palatal tissue | Experimental | Participants in this group will receive grafts including marginal and interdental palatal gingiva. |
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| Apical palatal tissue | Active Comparator | Participants in this group will receive grafts harvested from approximately 1.5 mm apical to the palatal gingival margin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronal palatal tissue | Procedure | This group will receive palatal grafts including marginal and interdental gingiva. This coronal palatal tissue will be applied to the peri-implant tissue at the second-stage implant surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant Mucosal Thickness | The primary outcome is the change in peri-implant mucosal thickness measured at four time points using clinical and digital methods. | Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading) |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinized Mucosa Width | Keratinized tissue width will be measured from the mid-buccal aspect of the edentulous area. | Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading) |
| Vestibular Depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ezgi Gürbüz | Contact | +905557411860 | ezgi.dogan@ksbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya Health Sciences University | Kütahya | Merkez | 43100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18266873 | Background | Zigdon H, Machtei EE. The dimensions of keratinized mucosa around implants affect clinical and immunological parameters. Clin Oral Implants Res. 2008 Apr;19(4):387-92. doi: 10.1111/j.1600-0501.2007.01492.x. Epub 2008 Feb 11. | |
| 27041111 | Background | Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation procedures at second-stage surgery: a systematic review. Clin Oral Investig. 2016 Sep;20(7):1369-87. doi: 10.1007/s00784-016-1815-2. Epub 2016 Apr 4. |
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Randomized controlled clinical trial with parallel groups
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Single blinded
| Apical palatal tissue | Procedure | This group will receive palatal grafts harvested from approximately 1.5 mm apical to the gingival margin. This graft will be applied to the peri-implant tissue at the second-stage implant surgery. |
|
Vestibular depth is defined as the vertical distance between the midcrestal area and the point of greatest concavity of the mucosal fold. |
| Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading) |
| Modified Plaque Index | Modified plaque index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3. | Postoperative 6th month after implant placement and 12th month after prosthetic loading |
| Modified Bleeding Index | Modified bleeding index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3. | Postoperative 6th month after implant placement and 12th month after prosthetic loading |
| Peri- implant Probing Depth | Peri-implant probing depth will be measured at six points around each implant. | Postoperative 6th month after implant placement and 12th month after prosthetic loading |
| Mucosal Recession | Mucosal recession will be measured as the distance between the implant abutment interface and the mucosal margin. | 12th month after prosthetic loading |
| Marginal Bone Level | Marginal bone level will be measured on periapical radiographs taken by the parallel technique. | Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading) |
| Pink Esthetic Score (PES) | Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score with a minimum value of 0 and a maximum of 14. | Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading |
| Postoperative Pain Assessment | Postoperative pain as patient-reported outcome will be recorded using a visual analog scale (VAS; 0-100). | Postoperative 14 days (daily after graft application) |
| Analgesic Consumption | The amount of analgesic medication used (mg) will be recorded. | Postoperative 14.days (after graft application) |
| Patient Satisfaction | Patient satisfaction with the surgical procedure will be assessed using a three-point Likert scale (0 = no, 1 = maybe, 2 = yes). | Postoperative 14.days (after graft application) |
| Patient-Perceived Esthetic Outcome | Patient perception of peri-implant soft tissue esthetics will be evaluated using a visual analog scale (VAS; 0-100). | 12th month after prosthetic loading |
| Oral Health-Related Quality of Life | Oral health-related quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire. | Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading |