Comparison of Short and Standard Dental Implants

NCT04475406 | Completed

• 1 other identifier: 2016/009
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: This study aimed to evaluate the total amounts of tumor necrosis factor α (TNF-α), prostaglandin E2 (PGE2), receptor activator of nuclear factor kappa B ligand (RANKL), receptor activator of nuclear factor kappa B (RANK), and osteoprotegerin (OPG) and the abundance of putative oral pathogens Fusobacterium nucleatum, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, and Streptococcus oralis in extra short and standard dental implants functioning in the posterior mandible. Methodology: The implants were divided into two groups according to their lengths: standard (intrabony length ≥8 mm) and extra short (intrabony length ≤ 6 mm). A total of 60 implants were researched in 30 patients. Probing depth (PD), clinical attachment level (CAL), presence of bleeding on probing (BOP), 3-year survival rate (CSR), and bone loss (BL) were measured.

Conditions

Peri-Implantitis; Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• the levels of putative oral pathogens (using PCR)

  An extraction kit was used in accordance with the manufacturer's recommendations to purify the DNA in the collected plaque samples (GF-1 bacterial DNA extraction kit, Vivantis, Malaysia). Standards were used for total DNA in the target bacteria. Primary probes were determined to define each bacterium and observe the proliferation curves using real-time polymerase chain reaction (PCR)

  an average of 3 year

Secondary Outcomes (1)

• total amount of TNF-α, PGE2, RANKL, RANK, and OPG (using ELISA)

  an average of 3 year

Study Arms (2)

Control group

SHAM COMPARATOR

Standard implant, intra-bone length ≥8 mm (30 implants)

Other: PICF (Periopaper); Other: Subgingival plaque, Gracey curette (Hu-Friedy); Other: Clinical data, williams probe PCPNU (Hu-Friedy)

Test group

ACTIVE COMPARATOR

Extra Short implant, intra-bone length ≤6 mm (30 implants)

Other: PICF (Periopaper); Other: Subgingival plaque, Gracey curette (Hu-Friedy); Other: Clinical data, williams probe PCPNU (Hu-Friedy)

Interventions

PICF (Periopaper) OTHER

After the plaques and soft attachments around the implants were removed, the implants were isolated using cotton rolls and dried with an air spray. The PICF was collected from the mesio-buccal region of the implant using periopaper strips (Oraflow Inc, NY, USA). Paper strips were placed 1-2 mm inside the peri-implant sulcus and kept for 30 s. Paper strips were placed in sterile Eppendorf tubes containing 200 µL of phosphate-buffered saline (PBS). The tubes were kept at -80°C until the analysis day. Paper strips contaminated with saliva or blood were excluded from the sampling.

Control group; Test group

Subgingival plaque, Gracey curette (Hu-Friedy) OTHER

After collecting the PICF, the supragingival plaque was carefully removed using a sterile scaler. Implants were isolated using cotton rolls and dried with an air spray. Subgingival plaque samples were collected from the mesio-buccal region of the implant using a sterile plastic Gracey curette (Hu-Friedy, Switzerland) for 30 s. The samples collected were transferred to sterile Eppendorf tubes containing 200 µL of PBS. The tubes were kept at -80°C until the analysis day.

Control group; Test group

Clinical data, williams probe PCPNU (Hu-Friedy) OTHER

A single calibrated examiner performed all (full-mouth and site-specific) clinical measurements (B.K.), including probing depth (PD), clinical attachment level (CAL), presence of bleeding on probing (BOP), 3-year survival rate (CSR), and bone loss (BL). The values of PD and BOP were measured from four sites of each implant (mesial, distal, buccal, and lingual) with a Williams type (Hue Friedy, Switzerland) plastic periodontal probe. The PD was recorded as the distance from the base of the peri-implant to the side of the gum in millimeters. BOP was evaluated according to the presence (+) or absence (-) of bleeding within the first 30 s following the measurement of PD.17 Control panoramic films of all patients were taken, and differences in the marginal bone level between radiography images after implant placement and 3 years later were evaluated. Original films and images taken later were taken with the same angle for standardizaton.

Control group; Test group

Eligibility Criteria

• Age: 35 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Implants placed by the same periodontologist (E.Ö.) functioning for at least 3 years
• Patients without any systemic disease affecting bone metabolism
• Age \>18 years
• Extra short (6-mm) implants with identical surface properties bilaterally in one area in the mandibular region and standard (≥8 mm) implants in the other area
• Placed implants having the same brand (Straumann Standard Plus; Institute Straumann AG, Basel, Switzerland)
• Patients with cemented implant prosthesis in which standard abutment was used in the mandibular posterior region
• Implants having no additional bone augmentation during implant surgery
• No periodontal treatment received in the last 3 years
• Patients under oral hygiene control (plaque score \<20%)

You may not qualify if:

• Poor oral hygiene (plaque score \>20%)
• Patients with a history of periodontitis
• Uncontrolled diabetes and other uncontrolled diseases
• Pregnancy and lactation
• Smoking more than 10 cigarettes a day
• Using alcohol
• Receiving radiotherapy and chemotherapy
• Using drugs suppressing the immune system
• Having a parafunctional habit

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Bilge Karcı, Dr.

  Alanya Alaaddin Keykubat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: December 15, 2016
• Primary Completion: March 20, 2017
• Study Completion: December 20, 2017
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share