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

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

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.

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

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Other: Anodic oxidation
* Other: Untreated abutment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodic Oxidation of implant abutment<br> | Other: Anodic oxidation<br>* 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.<br>|
| Sham Comparator: Untreated implant abutment<br> | Other: Untreated abutment<br>* Abutment will be left untreated with its gray color.<br>|

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 |