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NCT Number: NCT04305080

Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health

This research aims to evaluate the effect of anodic oxidation of implant abutment collar on the peri-implant soft tissue health.

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Key information

Conditions

Dental Implants

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

A randomized controlled clinical trial will be implemented on 10 implant abutments in five patients, each having 2 dental implants in the same quadrant. Abutments with standard silver collars will be divided into two groups: Group 1 (test group) will undergo anodic oxidation of the abutment collar changing it into pink color. Group 2 (control group) untreated abutments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy patients with good oral hygiene.
  • Having two inserted dental implants in the same quadrant with healing abutments.
  • Implants with at least 1 mm peri-implant soft tissue height.

Exclusion criteria

  • Patients with systemic conditions interfering with soft tissue health.
  • Heavy smoking.
  • Patients with inflamed gingival tissue or bad oral hygiene.
  • Diseased gingival tissue that needs periodontal treatment.

Treatment and study plan

Anodic oxidation

Other

Abutments will undergo anodic oxidation process after etching with Hydrofluoric acid & Nitric acid mixture for 10 minutes for debridement in a bath of distilled water with citric acid for 5 minutes to turn the abutment collar into pink color. The stainless steel plate will be connected to the cathode (-) and titanium abutments will be connected to the anode (+) end of the DC Power Supply. After then abutments will be left in distilled water for 10 minutes and sterilized before insertion in patient mouth.

Untreated abutment

Other

Abutment will be left untreated with its gray color.

Primary outcomes

  1. Pink aesthetic score

    Time frame: baseline

    Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.

  2. Pink aesthetic score

    Time frame: 6 months

    Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.

  3. Plaque index (Silness-Löe Index)

    Time frame: baseline

    This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

    2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  4. Plaque index (Silness-Löe Index)

    Time frame: 6 months

    This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

    2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  5. Probing depth

    Time frame: baseline

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  6. Probing depth

    Time frame: 6 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  7. Bleeding on probing

    Time frame: baseline

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  8. Bleeding on probing

    Time frame: 6 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

The Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health (Randomized Controlled Clinical Trial)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Oct 14, 2020

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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