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Completed

NCT Number: NCT02996370

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

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.

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Key information

Conditions

Tooth Loss Bone Diseases Bone Diseases, Metabolic Bone Loss Metabolic Diseases Mouth Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

papilla fill index

Other

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.

Crestal bone loss

Other

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)

Probing depth

Other

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

Modified sulcus bleeding index

Other

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

Modified plaque index

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2016
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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