Clinical trial NCT04305080: Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health
Official title: The Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-03-12
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pink aesthetic score
timeFrame: baseline
measure: Pink aesthetic score
timeFrame: 6 months
measure: Plaque index (Silness-Löe Index)
timeFrame: baseline
measure: Plaque index (Silness-Löe Index)
timeFrame: 6 months
measure: Probing depth
timeFrame: baseline
measure: Probing depth
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: baseline
measure: Bleeding on probing
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Khaled Farrag, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Moataz Khamis, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.