Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Study Overview
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Brief Summary
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Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.

Detailed Description
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A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.

Official Title
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Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Conditions
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Tooth Loss, Bone Loss

Intervention / Treatment
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* Other: papilla fill index
* Other: crestal bone loss
* Other: probing depth
* Other: Modified sulcus bleeding index
* Other: Modified plaque index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No sistemic condition, and age > 18 years, healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%, in a need of at least two collateral implants in the maxilla from second premolar to second premolar sufficient keratinized tissue no bone augmentation procedures before implant placement use of tobacco 10N ≥ cigarettes daily sufficient distance between opposite occluding dentition at the proposed implant sites Exclusion Criteria: history of aggressive periodontitis, systemic diseases such as diabetes pregnant or lactating women radiation therapy in the head and neck area wihtin the previous 12 months, heavy smokers bruxism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group- ı shape incision<br>Second stage surgery was made I shape incision technique . | Other: papilla fill index<br>* The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.<br>Other: crestal bone loss<br>* Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)<br>Other: probing depth<br>* The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Modified sulcus bleeding index<br>* Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.<br>Other: Modified plaque index<br>* Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.<br>|
| Active Comparator: Control group- midcrestal incision<br>In the control group second stage surgery was made using the conventional method, midcrestal technique. | Other: papilla fill index<br>* The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.<br>Other: crestal bone loss<br>* Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)<br>Other: probing depth<br>* The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Modified sulcus bleeding index<br>* Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.<br>Other: Modified plaque index<br>* Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| papilla fill index | Baseline will be 1 week after cementation of the crowns. | baseline | 
| papilla fill index | Papilla fill index will be recorded 3rd month after baseline | 3 month | 
| papilla fill index | Papilla fill index will be recorded 6th month after baseline | 6 month | 
| crestal bone loss | Crestal bone loss was measured on radiographs between baseline-3rd month. | Change from baseline crestal bone level up to 3 months | 
| crestal bone loss | Crestal bone loss was measured on radiographs between baseline-6th month. | Change from baseline crestal bone level up to 6 months | 
| vertical distance | Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs. | baseline, 3 and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe. | baseline | 
| Probing depth | The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe. | 3 month | 
| Probing depth | The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe. | 6 month | 
| Modified sulcus bleeding index | Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing. | Modified sulcus bleeding index was recorded at baseline | 
| Modified sulcus bleeding index | Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing. | Modified sulcus bleeding index was recorded at 3 month | 
| Modified sulcus bleeding index | Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing. | Modified sulcus bleeding index was recorded at 6 month | 
| Modified plaque index | The dichotomous presence of supra gingival plaque was recorded at four sites of implants | Modified plaque index was recorded at baseline | 
| Modified plaque index | The dichotomous presence of supra gingival plaque was recorded at four sites of implants | Modified plaque index was recorded at 3 month | 
| Modified plaque index | The dichotomous presence of supra gingival plaque was recorded at four sites of implants | Modified plaque index was recorded at 6 month | 
| Keratinized tissue level | Keratinized tissue level measured with a plastic periodontal probe | Keratinized tissue level was recorded at baseline | 
| Keratinized tissue level | Keratinized tissue level measured with a plastic periodontal probe | Keratinized tissue level was recorded at 3 month | 
| Keratinized tissue level | Keratinized tissue level measured with a plastic periodontal probe | Keratinized tissue level was recorded at 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery