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The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.
The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Two horizontal incisions placed 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. |
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| Control group | Experimental | Sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z shaped incision | Procedure | After local anaesthesia, a mucoperiosteal flap will be elevated at the edentulous ridge with two horizontal incisions placed with a no MB 69 blade, 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. The extend of the incisions should be up to the proximal line angles of the adjacent teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. A periosteal elevator is used to elevate a full thickness mucoperiosteal flap buccally and lingually to the level of the mucogingival junction, exposing the alveolar ridge of the implant surgical sites. Endosseous implant placement is done followed by simple interrupted resorbable sutures |
| Measure | Description | Time Frame |
|---|---|---|
| Inter proximal bone level | Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up | 6 months |
| Healing | Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analouge Score | a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded. | 7 days |
| Clinical attachment level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Shobith S Mampuzha, MDS | Rajiv Gandhi University of Health Sciences | Principal Investigator |
| Dr Prabhuji MLV, MDS | Rajiv Gandhi University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krishnadevaraya college of dental sciences | Bangalore | Karnataka | 562157 | India |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Two groups were made one test and control. All the subjects required rehabilitation with implants.In the test group Z shaped incision was placed. in control group sulcular H shaped incision was placed.
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| H shaped incision | Procedure | After local anaesthesia, a mucoperiosteal flap is elelevated by placing sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles using a MB 69 blade. Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth. A full thickness mucoperiosteal flap will be elevated buccally and lingually to the level of the mucogingival junction to expose the alveolar ridge of the implant surgical sites using a periosteal elevator. Endosseous implant will be placed, followed by simple interrupted resorbable sutures. |
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The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa |
| 3 months |