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Alveolar Bone LossNCT05595746

Radiological Bone Loss on Different Levels of Dental Implants

A study testing dental implant placement in people with Alveolar Bone Loss and Peri-Implantitis, run by Kutahya Health Sciences University 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

One of the criteria used for long-term implant success is the evaluation of radiographic bone loss. It is known that the keratinized mucosa over the alveolar crest forms a protective barrier against inflammatory infiltration. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
dental implant placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Oct 2020to 9 Mar 2023
Phase
Interventional
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >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 higher than 7 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 lactation
  • Mentally retarded patients
  • Immediate loading
  • Alveolar bone defects
  • Smoking more than 10 cigarettes per a day
  • Immunsupression or deficiency on 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

Official title: Evaluation of the Relationship Between Vertical Mucosal Thickness and Radiological Bone Loss of Platform-Switching Implants Placed at Different Levels

One of the criteria used for long-term implant success is the evaluation of radiographic bone loss. It is known that the keratinized mucosa over the alveolar crest forms a protective barrier against inflammatory infiltration. In addition, it has been reported that the vertical mucosal thickness on the crest is important in the formation of the biological width around the implant. The aim of this study was to evaluate the effect of vertical mucosal thickness on the alveolar crest on peri-implant marginal bone loss around crestal and subcrestal placed platform-switching implants. In this study, patients will be divided into 2 main groups with vertical mucosal thickness of 2 mm and less and more than 2 mm, and both groups will consist of 2 subgroups as crestally and subcrestally according to the implant level placed. A total of 80 implants will be included, 20 implants in each group. Before starting the surgery, after anesthesia is given, the width of the patient's peri-implant keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be measured. Clinical and radiological measurements will be made in all patients during the prosthetic loading session (T0), at 3rd month (T1), 6th month (T2) and 1 year after loading (T3). With standardized 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.

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 bone loss. It is known that the keratinized mucosa over the alveolar crest forms a protective barrier against inflammatory infiltration. It has been reported that the vertical mucosal thickness over the alveolar crest in the operation area before dental implant treatment is important in the formation of the biological width around the implant. There are studies in the literature examining the effects of vertical mucosal thickness on peri-implant marginal bone loss. In a study presented by Linkevicius et al., in 2014, they divided 80 patients into 2 groups according to their mucosal thickness. It was reported that radiological bone loss was 1.17 mm in the group with low vertical mucosal thickness at the end of 1-year follow-up, and 0.21 mm in the group with high vertical thickness.

The aim of the study was to evaluate the effect of vertical mucosal thickness on the alveolar crest on peri-implant marginal bone loss around crestal and subcrestal placed platform-switching implants.

Before starting the surgery, after the patient is anesthetized, the width of the peri-implant keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be measured. In this study, patients will be divided into 2 main groups with vertical mucosal thickness of 2 mm and less and more than 2 mm, and both groups will consist of 2 subgroups as crestal and subcrestal according to the implant level placed.

It is planned to use the same brand of implant and platform-switch abutment in patients. With standardized 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 software. Routine clinical and radiological measurements will be repeated in all patients at the prosthetic loading session (T0), at 3 months (T1), at 6 months (T2), and 1 year after loading (T3). Pre-surgical radiographs will be taken from the patients who participated in our study, as in all implant patients 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, 60 implants were planned to be taken for α= 0.05 and 80% power. However, since the study is a long-term control study, it is planned to take 20 implants each, due to the risk of patients not coming to the control sessions. A total of 80 implants will be included.

Statistical analysis method: All analyzes will be done with (Statistical Package for the Social Sciences) SPSS software. 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 by independent sample-T or Mann Whitney U test according to their normal distribution. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. The significance value will be taken as 0.05. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.

Being tested
dental implant placement
Keywords
vertical mucosal height, dental implant, marginal bone loss, keratinized gingival width
Medical subject headings
Alveolar Bone Loss, Peri-Implantitis

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 dental implant placement surgery, first of all, intraoral infiltrative anesthesia is applied to the area. After the crestal incision, the buccal flap is elevated to full thickness. Vertical mucosal height is measured with a William type standard periodontal probe. The palatal/lingual flap is then elevated to full thickness. The implant is placed at different levels with the standard protocol determined by the manufacturer. Study groups are determined by the placement levels of the implants and the vertical mucosal height measurement values. After the implants are placed, the flap is closed primarily.

Study groups in NCT05595746
Study groupRoleWhat they receive
equicrestally placement with higher vertical mucosaExperimentalImplants with a vertical mucosal height greater than 2 mm (A) and placed equicrestally (I) are in group A-I.
Receives: Procedure: dental implant placement
subcrestally placement with higher vertical mucosaExperimentalImplants with a vertical mucosal height greater than 2 mm (A) and placed subcrestally (II) are in group A-II.
Receives: Procedure: dental implant placement
equicrestally placement with less vertical mucosaExperimentalImplants with a vertical mucosal height of 2 mm or less (B) and placed equicrestally (I) are in group B-I.
Receives: Procedure: dental implant placement
subcrestally placement with less vertical mucosaExperimentalImplants with a vertical mucosal height of 2 mm or less (B) and placed subcrestally (II) are in group B-II.
Receives: Procedure: dental implant placement

What is being measured

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

  1. Radiographic peri-implant marginal bone loss

    It is the result to be obtained by radiographic evaluation of peri-implant marginal bone loss of 4 study groups formed by vertical mucosal height and implant placement levels.

    Measured: 1 year after prosthetic loading

Secondary outcomes (6)
  1. Marginal bone loss related keratinized gingival height

    Peri-implant marginal bone loss with keratinized gingival height

    Measured: 1 year after prosthetic loading

  2. Marginal bone loss related keratinized gingival thickness

    Peri-implant marginal bone loss with keratinized gingival thickness

    Measured: 1 year after prosthetic loading

  3. Evaluation of clinical peri-implant health with plaque index

    Peri-implant plaque index clinical data will be used.

    Measured: 1 year after prosthetic loading

  4. Evaluation of clinical peri-implant health with gingival index

    Peri-implant gingival index clinical data will be used.

    Measured: 1 year after prosthetic loading

  5. Evaluation of clinical peri-implant health with bleeding on probing index

    Peri-implant bleeding on probing clinical data will be used.

    Measured: 1 year after prosthetic loading

  6. Evaluation of clinical peri-implant health with pocket depth on probing index

    Peri-implant pocket depth on probing clinical data will be used.

    Measured: 1 year after prosthetic loading

Timeline

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

  1. First posted27 Oct 2022
  2. Study start5 Oct 2020
  3. Primary completion9 Mar 2022
  4. Study completion9 Mar 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Controlled, non-randomized, single-blind, parallel
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595746
Sponsor's protocol ID
2020-05/07
Status last verified
Nov 2023
First submitted
16 Oct 2022
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data can be shared if the principal investigator is contacted.

Publications

  • Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9.

    PubMed 19885413
  • Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.

    PubMed 24313250
  • Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.

    PubMed 24673875
  • Terzioglu B, Ayyildiz BG. Effect of supracrestal tissue height on marginal bone level changes at platform-switching dental implants placed crestally and subcrestally: A randomized clinical-trial. J Dent. 2024 Sep;148:105219. doi: 10.1016/j.jdent.2024.105219. Epub 2024 Jul 1.

    PubMed 38960001

Questions about this trial

What is this clinical trial studying?

A study testing dental implant placement in people with Alveolar Bone Loss and Peri-Implantitis, run by Kutahya Health Sciences University 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 7 inclusion and 6 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 Nov 2023. 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?

Radiographic peri-implant marginal bone loss (time frame: 1 year after prosthetic loading). 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 NCT05595746, which also lists 4 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 Nov 2023.

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