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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Other: Anodic oxidation; Other: Untreated abutment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodic Oxidation of implant abutment	Other: 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.
Sham Comparator: Untreated implant abutment	Other: Untreated abutment; Abutment will be left untreated with its gray color.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink aesthetic score	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.	baseline
Pink aesthetic score	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.	6 months
Plaque index (Silness-Löe Index)	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.	baseline
Plaque index (Silness-Löe Index)	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.	6 months
Probing depth	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	baseline
Probing depth	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	6 months
Bleeding on probing	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	baseline
Bleeding on probing	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	6 months

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Khaled Farrag, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Moataz Khamis, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): October 7, 2020

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Anodic oxidation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No