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

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ClinicalTrials.gov Identifier: NCT02996370
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Özge PEHLİVANOĞLU, Ege University

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.

Condition or disease Intervention/treatment Phase
Tooth Loss Bone Loss Other: papilla fill index Other: crestal bone loss Other: probing depth Other: Modified sulcus bleeding index Other: Modified plaque index Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: Test group- ı shape incision
Second stage surgery was made I shape incision technique .
Other: papilla fill index
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.

Other: crestal bone loss
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)

Other: probing depth
The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Other: Modified sulcus bleeding index
Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Other: Modified plaque index
Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Active Comparator: Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
Other: papilla fill index
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.

Other: crestal bone loss
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)

Other: probing depth
The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Other: Modified sulcus bleeding index
Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Other: Modified plaque index
Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.




Primary Outcome Measures :
  1. papilla fill index [ Time Frame: baseline ]
    Baseline will be 1 week after cementation of the crowns.

  2. papilla fill index [ Time Frame: 3 month ]
    Papilla fill index will be recorded 3rd month after baseline

  3. papilla fill index [ Time Frame: 6 month ]
    Papilla fill index will be recorded 6th month after baseline

  4. crestal bone loss [ Time Frame: Change from baseline crestal bone level up to 3 months ]
    Crestal bone loss was measured on radiographs between baseline-3rd month.

  5. crestal bone loss [ Time Frame: Change from baseline crestal bone level up to 6 months ]
    Crestal bone loss was measured on radiographs between baseline-6th month.

  6. vertical distance [ Time Frame: baseline, 3 and 6 month ]
    Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: baseline ]
    The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.

  2. Probing depth [ Time Frame: 3 month ]
    The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.

  3. Probing depth [ Time Frame: 6 month ]
    The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.

  4. Modified sulcus bleeding index [ Time Frame: Modified sulcus bleeding index was recorded at baseline ]
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.

  5. Modified sulcus bleeding index [ Time Frame: Modified sulcus bleeding index was recorded at 3 month ]
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.

  6. Modified sulcus bleeding index [ Time Frame: Modified sulcus bleeding index was recorded at 6 month ]
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.

  7. Modified plaque index [ Time Frame: Modified plaque index was recorded at baseline ]
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants

  8. Modified plaque index [ Time Frame: Modified plaque index was recorded at 3 month ]
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants

  9. Modified plaque index [ Time Frame: Modified plaque index was recorded at 6 month ]
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants

  10. Keratinized tissue level [ Time Frame: Keratinized tissue level was recorded at baseline ]
    Keratinized tissue level measured with a plastic periodontal probe

  11. Keratinized tissue level [ Time Frame: Keratinized tissue level was recorded at 3 month ]
    Keratinized tissue level measured with a plastic periodontal probe

  12. Keratinized tissue level [ Time Frame: Keratinized tissue level was recorded at 6 month ]
    Keratinized tissue level measured with a plastic periodontal probe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Özge PEHLİVANOĞLU, Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry, Ege University
ClinicalTrials.gov Identifier: NCT02996370     History of Changes
Other Study ID Numbers: EGE-OP 2013
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Özge PEHLİVANOĞLU, Ege University:
esthetic
inter-implant papilla
soft tissue tickness
crestal bone loss
second stage surgery

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases