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Bone Loss, AlveolarNCT05592821

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

An observational study of Bone Loss, Alveolar and Dental Implant Failed, run by Berceste Guler at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bone Loss, Alveolar, Dental Implant Failed
What is being tested?
dental implant placement
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Dec 2020to 26 Sep 2023
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

    Kütahya, 43100

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

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. The effects of bone and tissue level implants and peri-implant keratinized mucosa on marginal bone loss have been studied in the literature. In 2018, Vianna conducted research on 40 implants, 20 at the bone level and 20 at the tissue level, in split mouth design in 20 chronic periodontitis patients. Insufficient height of the peri-implant keratinized mucosa may cause sensitivity and pain during tooth brushing. This affects the patient's quality of life negatively, and also shortens the long-term survival of the implant as it may cause peri-implant alveolar bone loss and inflammation due to plaque deposition. It is known that the width of the keratinized gingiva decreases anatomically from anterior to posterior.

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. Before starting the surgery, after anesthesia is given, the width of the patient's peri-implant keratinized mucosa and the gingival height at the top of the alveolar crest will be measured. 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.

Clinical measurements

  1. Plaque index (Löe \& Silness) and gingival index (Silness \& Löe) are obtained by measuring 4 regions of a tooth (mesial, distal, buccal and lingual) with a Williams periodontal probe. Attachment loss: It is the value of the distance between a tooth and the free gingiva, based on the enamel-cementum junction, measured using a Williams periodontal probe.
  2. Bleeding on probing index (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
  3. Keratinized gingival width: It is the distance from the free gingival margin to the mucogingival junction line.
  4. Vertical mucosal thickness: It is the distance from the apex of the alveolar crest to the gingival margin. It will be measured with a standardized William type probe.
  5. Pocket depth: The vertical distance between the base of the periodontal sulcus and the gingival margin with a standard periodontal probe.
  6. Peri-implant pocket depth: It is the vertical distance between the base of the peri-implant sulcus and the gingival margin.
  7. Marginal bone level: Radiographic evaluation of the distance between the restoration margin and the bone level

Sample Selection: Taking the effect size of 0.08 for the significance value in the G Power analysis program as a reference to a previously presented study, 20 patients and 40 implants were planned to be taken for α= 0.05 and 80% power.

Statistical analysis method: All analyzes will be done with the (Statistical Package for the Social Sciences) SPSS software program. In-group temporal evaluations in test and control groups will be evaluated using Paired sample -T or Wilcoxon test according to normal distribution values. For comparisons between groups, the data will be analyzed with the Independent sample-T or Mann Whitney U test according to the normal distribution. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.

Being tested
dental implant placement
Keywords
Soft tissue level implants, Bone level implants, Marginal bone loss, Two-piece abutment concept
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dental implant placementProcedure or surgery

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

Study groups in NCT05592821
Study groupRoleWhat they receive
Test Group: soft tissue level implantsIn 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
Receives: Procedure: dental implant placement
Control Group: bone level implantsIn 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
Receives: Procedure: dental implant placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peri-implant marginal bone loss.

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

    Measured: 1 year following prosthetic restoration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start7 Dec 2020
  3. Primary completion26 Sep 2022
  4. Study completion26 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
20 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592821
Sponsor's protocol ID
2020/09-06
Status last verified
Mar 2024
First submitted
20 Oct 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data (IPD) will be shared if the principal investigator is contacted.

Publications

  • 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.

    PubMed 22889084
  • 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.

    PubMed 27469547
  • 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.

    PubMed 40907027

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Loss, Alveolar and Dental Implant Failed, run by Berceste Guler at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-implant marginal bone loss. (time frame: 1 year following prosthetic restoration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592821, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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