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

NCT04305080 | Completed

• 1 other identifier: Anodic oxidation
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Anodic Oxidation of implant abutment

EXPERIMENTAL

Other: Anodic oxidation

Untreated implant abutment

SHAM COMPARATOR

Other: Untreated abutment

Interventions

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.

Anodic Oxidation of implant abutment

Untreated abutment OTHER

Abutment will be left untreated with its gray color.

Untreated implant abutment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (3)

• 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.

  PMID: 19120783 BACKGROUND

• 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.

  PMID: 21607937 BACKGROUND

• 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.

  PMID: 16307569 BACKGROUND

Study Officials

• Khaled Farrag, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Moataz Khamis, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health and Statistician

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: October 20, 2019
• Primary Completion: August 15, 2020
• Study Completion: October 7, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

EG (1)