Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants: Two-piece Abutment Concept

NCT05592821 | Completed

• 1 other identifier: 2020/09-06
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Dental implants have become one of the most common treatments used for the rehabilitation of lost teeth. The success rate of dental implant treatment is quite high. One of the criteria used for long-term implant success is the evaluation of radiographic marginal bone loss. Implants are used at the bone and tissue level in implant treatment. In this study, it was planned to use 20 implants of the same brand, with a single implant in the bilateral posterior regions in 10 patients.The study will be designed as split-mouth. The implant will be placed at the bone level with the same protocol in the two edentulous areas and the flap will be closed primarily. After 3 months, the substructure of the two-piece abutment concept system will be placed in a region during the healing head placement stage, and the bone level implant will be converted to the tissue level. A conventional healing cap will be placed in the other area. Periapical radiographs will be taken from the patients who participated in our study, as in all implant patients, during the pre-surgical planning phase and after implant placement. With the control periapical radiographs to be taken as a result of one-year follow-up, the marginal bone loss amount in the implants will be evaluated using soft-ware. Clinical measurements will be taken in all patients at the prosthetic loading session and 1 year after loading.

Conditions

Bone Loss, Alveolar; Dental Implant Failed

Keywords

Soft tissue level implants; Bone level implants; Marginal bone loss; Two-piece abutment concept

Outcome Measures

Primary Outcomes (1)

• Peri-implant marginal bone loss.

  Comparison of the 2 groups in terms of the amount of marginal bone loss.

  1 year following prosthetic restoration.

Study Arms (2)

Test Group: soft tissue level implants

In this study, it was planned to use 20 implants of the same brand, with a single implant in the bilateral posterior regions in 10 patients. While the bone level implant is placed on one side of the patients, the tissue level implant will be used on the other side. The study will be designed as split-mouth. The type of implant to be placed in the regions will be decided according to the amount of keratinized gingival level above the alveolar crest level. Soft tissue level implants are in this group

Procedure: dental implant placement

Control Group: bone level implants

In this study, it was planned to use 20 implants of the same brand, with a single implant in the bilateral posterior regions in 10 patients. While the bone level implant is placed on one side of the patients, the tissue level implant will be used on the other side. The study will be designed as split-mouth. The type of implant to be placed in the regions will be decided according to the amount of keratinized gingival level above the alveolar crest level. Bone level implants are in this group

Procedure: dental implant placement

Interventions

dental implant placement PROCEDURE

In both groups, dental implants of the same brand will be placed into the bone with the same protocol.

Control Group: bone level implants; Test Group: soft tissue level implants

Eligibility Criteria

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

Study Population

Apply to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology.

You may qualify if:

• Being over 18 years old
• The patient does not have any systemic disease
• Implants are placed in the fully healed alveolar bone
• There is no need for horizontal and vertical augmentation in the area where the implant will be placed.
• Interocclusal distance greater than 7 mm
• The edentulous space is free-ended or the mesiodistal width in the interdental region is at least 6 mm
• Cooperative patients
• At least 9 mm of alveolar bone in the patient's mandible or maxilla in the area where the implant will be placed

You may not qualify if:

• Pregnant and breastfeeding women
• Mentally retarded patients
• Patients with immediate loading
• Patients with lesions in the alveolar bone
• Patients who smoke more than 10 cigarettes per day
• Patients who use drugs that suppress the immune system or impair recovery
• Patients using drugs that disrupt bone metabolism

Sponsors & Collaborators

• Berceste Guler: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (3)

• Fernandez-Formoso N, Rilo B, Mora MJ, Martinez-Silva I, Diaz-Afonso AM. Radiographic evaluation of marginal bone maintenance around tissue level implant and bone level implant: a randomised controlled trial. A 1-year follow-up. J Oral Rehabil. 2012 Nov;39(11):830-7. doi: 10.1111/j.1365-2842.2012.02343.x. Epub 2012 Aug 13.

  PMID: 22889084 RESULT

• Lopez MA, Andreasi Bassi M, Confalone L, Gaudio RM, Lombardo L, Lauritano D. Retrospective study on bone-level and soft-tissue-level cylindrical implants. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2 Suppl 1):43-8.

  PMID: 27469547 RESULT

• Ayyildiz BG, Terzioglu B, Bayindir BC. The Effect of Two-Piece Abutment Concept and Abutment Reconnection/Disconnection on Marginal Bone Level Changes: A Split-Mouth Randomized, Parallel-Designed, 36-Month Follow-Up, Preliminary Clinical Study. Int J Oral Maxillofac Implants. 2025 Sep 4;0(0):1-28. doi: 10.11607/jomi.11454. Online ahead of print.

  PMID: 40907027 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berceste Güler

  Kütahya Health Sciences University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: December 7, 2020
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the research paper is published.
• Access Criteria: The IPD will be shared if the principal investigator is contacted.

Locations

TU (1)