Proteomic Analysis of Newly Restored Single Implants

NCT06379022 | Completed

• 1 other identifier: AUTh-29/21-11-2018
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In 10 systemically healthy non-smokers, free of periodontitis, one newly restored implant (baseline-T0) and one corresponding tooth were followed over 12 months (T1). All implants were screw-retained, and platform-switched. Oral hygiene was closely monitored during the study. Probing pocket depth (PPD), attachment levels (CAL), bleeding and plaque indices and crevicular fluid were collected from an implant-site (PICF) and a tooth-site (GCF). Total proteomic profiles in PICF and GCF were investigated using label-free quantitative proteomics.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Periodontal Diseases

Keywords

Peri-implant tissue; tissue remodeling; first year of function; proteomics; crevicular fluid; periodontal parametres

Outcome Measures

Primary Outcomes (2)

• Probing pocket depth

  Assessed by a periodontal probe

  baseline and 12 months

• Protein expression

  proteomic analysis

  baseline and 12 months

Secondary Outcomes (3)

• Recession

  baseline and 12 months

• Bleeding upon probing

  baseline and 12 months

• Inflammation index

  baseline and 12 months

Study Arms (2)

Implant unit

Newly restored single implant that is closely followed for plaque control

Behavioral: Plaque control

Tooth unit

A contralateral tooth that is closely followed for plaque control

Behavioral: Plaque control

Interventions

Plaque control BEHAVIORAL

Subjects are motivated for optimal oral hygiene

Implant unit; Tooth unit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: self reported if not overt
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy non-smokers, who were previously treated for periodontal disease and recently received implant therapy; Each subject contributed with one newly restored screw-retained implant 2-4 weeks following functional loading (baseline, T0) and was closely followed over 12 months (T1).

You may qualify if:

• systemically healthy non-smokers having a single implant prosthetically restored (2-4 weeks).

You may not qualify if:

• younger than 18 years of age, \<18 teeth (excluding third molars), untreated periodontal disease, periodontitis Stage III-IV, evidence of peri-implantitis (Berglundh et al, 2018) at other implant sites, significant soft tissue pathology, untreated carious cavities (five or more), systemic diseases that require intake of medications, medical conditions that contraindicated surgical implant placement, the medication that interferes with bone metabolism, pregnancy or lactation, inadequate dimensions of the alveolar ridge or grafted bone at the surgical site, and tooth extraction 3 months prior to the study, smoking.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Dental School, Aristotle University

Thessaloniki, 54124, Greece

Location

Related Publications (1)

• Apatzidou DA, Violesti A, Konstantinidis A, Bao K, Silbereisen A, Bostanci N. Protein profile at newly restored implants compared to contralateral teeth over 12-months: a pilot study. Clin Oral Investig. 2024 Oct 11;28(11):590. doi: 10.1007/s00784-024-05984-w.

  PMID: 39390228 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples of crevicular fluid collected from the periodontal and the peri-implant crevice

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Danae A Apatzidou, Assoc. Professor

  Dental School, Aristotle University

  STUDY CHAIR

• Danae A Apatzidou, Assoc. Professor

  Dental School, Aristotle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: December 3, 2018
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)