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

NCT ID: NCT04305080

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2020-10-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anodic Oxidation of implant abutment

Group Type EXPERIMENTAL

Anodic oxidation

Intervention Type 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 implant abutment

Group Type SHAM_COMPARATOR

Untreated abutment

Intervention Type OTHER

Abutment will be left untreated with its gray color.

Interventions

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Anodic oxidation

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.

Intervention Type OTHER

Untreated abutment

Abutment will be left untreated with its gray color.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Instructor of Dental Public Health and Statistician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Khaled Farrag, BDS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Moataz Khamis, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Gehrke P, Lobert M, Dhom G. Reproducibility of the pink esthetic score--rating soft tissue esthetics around single-implant restorations with regard to dental observer specialization. J Esthet Restor Dent. 2008;20(6):375-84; discussion 385. doi: 10.1111/j.1708-8240.2008.00212.x.

Reference Type BACKGROUND
PMID: 19120783 (View on PubMed)

Diamanti MV, Del Curto B, Pedeferri M. Anodic oxidation of titanium: from technical aspects to biomedical applications. J Appl Biomater Biomech. 2011 Jan-Apr;9(1):55-69. doi: 10.5301/JABB.2011.7429.

Reference Type BACKGROUND
PMID: 21607937 (View on PubMed)

Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

Reference Type BACKGROUND
PMID: 16307569 (View on PubMed)

Other Identifiers

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Anodic oxidation

Identifier Type: -

Identifier Source: org_study_id

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