Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Primary Purpose
Tooth Loss, Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
papilla fill index
crestal bone loss
probing depth
Modified sulcus bleeding index
Modified plaque index
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test group- ı shape incision
Control group- midcrestal incision
Arm Description
Second stage surgery was made I shape incision technique .
In the control group second stage surgery was made using the conventional method, midcrestal technique.
Outcomes
Primary Outcome Measures
papilla fill index
Baseline will be 1 week after cementation of the crowns.
papilla fill index
Papilla fill index will be recorded 3rd month after baseline
papilla fill index
Papilla fill index will be recorded 6th month after baseline
crestal bone loss
Crestal bone loss was measured on radiographs between baseline-3rd month.
crestal bone loss
Crestal bone loss was measured on radiographs between baseline-6th month.
vertical distance
Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
Secondary Outcome Measures
Probing depth
The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Probing depth
The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
Probing depth
The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02996370
Brief Title
Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Official Title
Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss, Bone Loss
Keywords
esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group- ı shape incision
Arm Type
Active Comparator
Arm Description
Second stage surgery was made I shape incision technique .
Arm Title
Control group- midcrestal incision
Arm Type
Active Comparator
Arm Description
In the control group second stage surgery was made using the conventional method, midcrestal technique.
Intervention Type
Other
Intervention Name(s)
papilla fill index
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
crestal bone loss
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
probing depth
Intervention Description
The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
Intervention Type
Other
Intervention Name(s)
Modified sulcus bleeding index
Intervention Description
Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
Intervention Type
Other
Intervention Name(s)
Modified plaque index
Intervention Description
Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
Primary Outcome Measure Information:
Title
papilla fill index
Description
Baseline will be 1 week after cementation of the crowns.
Time Frame
baseline
Title
papilla fill index
Description
Papilla fill index will be recorded 3rd month after baseline
Time Frame
3 month
Title
papilla fill index
Description
Papilla fill index will be recorded 6th month after baseline
Time Frame
6 month
Title
crestal bone loss
Description
Crestal bone loss was measured on radiographs between baseline-3rd month.
Time Frame
Change from baseline crestal bone level up to 3 months
Title
crestal bone loss
Description
Crestal bone loss was measured on radiographs between baseline-6th month.
Time Frame
Change from baseline crestal bone level up to 6 months
Title
vertical distance
Description
Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
Time Frame
baseline, 3 and 6 month
Secondary Outcome Measure Information:
Title
Probing depth
Description
The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Time Frame
baseline
Title
Probing depth
Description
The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
Time Frame
3 month
Title
Probing depth
Description
The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
Time Frame
6 month
Title
Modified sulcus bleeding index
Description
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Time Frame
Modified sulcus bleeding index was recorded at baseline
Title
Modified sulcus bleeding index
Description
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Time Frame
Modified sulcus bleeding index was recorded at 3 month
Title
Modified sulcus bleeding index
Description
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Time Frame
Modified sulcus bleeding index was recorded at 6 month
Title
Modified plaque index
Description
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Time Frame
Modified plaque index was recorded at baseline
Title
Modified plaque index
Description
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Time Frame
Modified plaque index was recorded at 3 month
Title
Modified plaque index
Description
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Time Frame
Modified plaque index was recorded at 6 month
Title
Keratinized tissue level
Description
Keratinized tissue level measured with a plastic periodontal probe
Time Frame
Keratinized tissue level was recorded at baseline
Title
Keratinized tissue level
Description
Keratinized tissue level measured with a plastic periodontal probe
Time Frame
Keratinized tissue level was recorded at 3 month
Title
Keratinized tissue level
Description
Keratinized tissue level measured with a plastic periodontal probe
Time Frame
Keratinized tissue level was recorded at 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
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