MicroRNAs and Cytokines in Peri-Implantitis Tissue

NCT05765942 | Unknown

• 1 other identifier: 534622
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a non-linear and accelerating pattern of loss of supporting bone tissue associated with clinical signs of inflammation and increased probing depths compared to baseline measurements. It can present as an asymptomatic condition with infection and fast progression of bone resorption or clinically symptomatic with mucosal inflammation, redness, edema, mucosal enlargement, bleeding on probing (BOP), suppuration, increased probing depth, and radiographic bone loss. The host immune defense against bacterial challenge is responsible for the damage, and the local immune-inflammatory process is associated with disrupted bone remodeling. New studies looking for predictive and accurate early biomarkers for this pathology have the utmost relevance. David Baltimore et al. proposed a feedback loop involving miRNA-146a and TLR signaling, which has been shown to be up-regulated in inflammatory diseases such as osteoarthritis and rheumatoid arthritis. miRNA-146a and miRNA-155 were the first miRNAs identified to be induced in immune cells stimulated by TLRs and proinflammatory cytokines. Precision medicine uses molecular research and different biomarkers, population studies, and big data analysis to recreate complex disease models. Several studies have compared the miRNA profiles of patients with periodontitis with healthy patients. Although periodontitis and peri-implantitis share many features, researchers' findings of periodontitis are not necessarily applicable to peri-implantitis. In fact, based on emerging evidence, peri-implantitis, and periodontitis exhibit several key differences, including their histopathological and molecular characteristics. Considering the aforementioned analysis, inflammatory miRNAs may be differentially expressed in peri-implantitis tissue compared with healthy gingival tissue. This study will investigate the gene expression levels of miRNA-146a and miRNA-155 and their correlation with inflammatory levels of their target genes in human gingival tissue surrounding dental implants diagnosed with peri-implantitis and health.

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• Level of miRNAs expressed in gingival tissue

  Level of miRNA (146a-5p and 155-5p) per fold change expressed in gingival tissue surrounding dental implants diagnosed with peri-implantitis and health.

  4 days

Secondary Outcomes (1)

• Level of mRNAs expressed in gingival tissueLevel

  4 days

Study Arms (2)

Implant surgery for harvesting healthy implant tissue (group HP)

the preoperative mucosal thickness will be measured clinically using a periodontal probe. A crestal incision will be performed, and a full-thickness flap will be elevated. Following the osteotomy, one or more implants measuring 4.5 or 5.0 mm in diameter will be placed. The implant platform will be positioned 0.5 mm below the bone level. A narrow-diameter healing abutment designed specifically for this study will be screwed in at 20 N, and flaps will be repositioned and sutured to obtain optimal adaptation of the mucosa to the titanium abutment. Healthy tissue samples will be harvested after 2 months of healing. Before the surgery, a guide pin will be connected to each healing abutment, attached to a circular punch 5 mm wide and with a cutting edge, which screwed apically around the abutment. Hence, a 1.5 mm thick collar of peri-implant soft tissue will be harvested Then, a new 4.5-5.0 mm-wide smooth-surfaced healing abutment will be connected to the implant directly.

Implant surgery for harvesting peri-implantitis tissue (group PP)

In each patient, at least one implant site demonstrating signs of peri-implantitis will be selected for biopsy. The site will be anesthetized and two parallel incisions, about 3mm apart, will be made with a 15C scalpel blade through the soft tissue until bone contact would be achieved. The 2 incisions will be connected with a perpendicular incision that will be placed at a distance of 4 mm from the proximal surface of the implant. The biopsies, including the entire supra-crestal soft tissue portion of the diseased site, will be carefully retrieved

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients will be selected from private clinics in Baghdad, seeking dental implant treatments. The peri-implant healthy group (control group) will involve those who are seeking to replace missing teeth with dental implants. While, the peri-implantitis patients (test group) will involve those who will be diagnosed with peri-implantitis and need surgical intervention during their follow up visits.

You may qualify if:

• Peri-implant health (control group):
• Adult patient age between \>18years.
• Having one or more missing teeth will be replaced with dental implants.
• Having adequate bone quality and availably for implant placement of 4.5-5 mm diameter and 8.5-13 mm length.
• Having keratinized mucosa of at least 3mm.
• Having no systemic disorders contraindicating to have peri-implant therapy.
• Peri-implantitis (test group):
• Adult patient age between \>18 years old.
• Having at least one implant with \> 1 year in function.
• Presence of bleeding and/or suppuration on gentle probing.
• Increased probing pocket depth (PPD) compared with previous baseline data
• Presence of bone loss beyond initial bone remodeling levels.
• In the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of:
• Presence of bleeding and/or suppuration on gentle probing.
• PPD of ≥6 mm.

You may not qualify if:

• Chronic inflammatory diseases such as : type 1 or 2 diabetes, cardiovascular or autoimmune diseases, and active infectious diseases.
• Systemic or topical antimicrobial/anti-inflammatory therapy for the 3 months prior to the beginning of the study.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Munir

Baghdad, Iraq

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue biopsy

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

IR (1)