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The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:
Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?
Our study consists of 2 groups:
The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).
The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).
Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smoker | Experimental |
| |
| non-smoker | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free gingival graft | Procedure | After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface. |
| Measure | Description | Time Frame |
|---|---|---|
| The three-dimensional changes of free gingival graft | An intraoral digital scanner will be used to assess the graft's dimensions alterations. | Baseline |
| The three-dimensional changes of free gingival graft. | An intraoral digital scanner will be used to assess the graft's dimensions alterations. | 1st month |
| The three-dimensional changes of free gingival graft | An intraoral digital scanner will be used to assess the graft's dimensions alterations. | 3rd month |
| The three-dimensional changes of free gingival graft | An intraoral digital scanner will be used to assess the graft's dimensions alterations. | 6th month |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | 0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayse E Selman | Contact | +905366393184 | aselman@biruni.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Recruiting | Istanbul | Turkey (Türkiye) |
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| Plaque index |
0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque |
| 1st month |
| Plaque index | 0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque | 3rd month |
| Plaque index | 0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque | 6th month |
| Gingival Index | 0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding | Baseline (prior to therapy) |
| Gingival Index | 0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding | 1st month |
| Gingival Index | 0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding | 3rd month |
| Gingival Index | 0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding | 6th month |
| Bleeding on probing | Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants. | Baseline |
| Bleeding on probing | Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants. | 1st month |
| Bleeding on probing | Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants. | 3rd month |
| Bleeding on probing | Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants. | 6th month |
| Keratinized mucosa width | The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe. | Baseline (prior to therapy) |
| Keratinized mucosa width | The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe. | 1st month |
| Keratinized mucosa width | The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe. | 3rd month |
| Keratinized mucosa width | The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe. | 6th month |
| Probing depth | Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe. | Baseline |
| Probing depth | Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe. | 1st month |
| Probing depth | Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe. | 3rd month |
| Probing depth | Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe. | 6th month |
| Wound healing | Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded. | 10th day |
| Wound healing | Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded. | 1st month |
| Wound healing | Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded. | 3rd month |
| Wound healing | Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded. | 6th month |
| Patient reported outcomes | After the surgical procedure, patients will be asked to complete a form consisting of 4 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days), (3) number of analgesic tablets taken, and (4) willingness to undergo the same surgery again (yes/no). | 10th day |