Radiological Bone Loss on Different Levels of Dental Implants

NCT05595746 | Completed

• 1 other identifier: 2020-05/07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alveolar Bone Loss; Peri-Implantitis; Bone Loss in Jaw

Keywords

vertical mucosal height; dental implant; marginal bone loss; keratinized gingival width

Outcome Measures

Primary Outcomes (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.

  1 year after prosthetic loading

Secondary Outcomes (6)

• Marginal bone loss related keratinized gingival height

  1 year after prosthetic loading

• Marginal bone loss related keratinized gingival thickness

  1 year after prosthetic loading

• Evaluation of clinical peri-implant health with plaque index

  1 year after prosthetic loading

• Evaluation of clinical peri-implant health with gingival index

  1 year after prosthetic loading

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

  1 year after prosthetic loading

Study Arms (4)

equicrestally placement with higher vertical mucosa

EXPERIMENTAL

Implants with a vertical mucosal height greater than 2 mm (A) and placed equicrestally (I) are in group A-I.

Procedure: dental implant placement

subcrestally placement with higher vertical mucosa

EXPERIMENTAL

Implants with a vertical mucosal height greater than 2 mm (A) and placed subcrestally (II) are in group A-II.

Procedure: dental implant placement

equicrestally placement with less vertical mucosa

EXPERIMENTAL

Implants with a vertical mucosal height of 2 mm or less (B) and placed equicrestally (I) are in group B-I.

Procedure: dental implant placement

subcrestally placement with less vertical mucosa

EXPERIMENTAL

Implants with a vertical mucosal height of 2 mm or less (B) and placed subcrestally (II) are in group B-II.

Procedure: dental implant placement

Interventions

dental implant placement PROCEDURE

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.

equicrestally placement with higher vertical mucosa; equicrestally placement with less vertical mucosa; subcrestally placement with higher vertical mucosa; subcrestally placement with less vertical mucosa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19885413 RESULT

• 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.

  PMID: 24313250 RESULT

• 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.

  PMID: 24673875 RESULT

• 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.

  PMID: 38960001 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss; Peri-Implantitis

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are assigned a number by hiding their names. While the measurements are being made, the researcher does not know which group the participant belongs to. All radiographic and clinic measurements are collected in one file.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Controlled, non-randomized, single-blind, parallel

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 27, 2022
• Study Start: October 5, 2020
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Following acceptance of manuscript
• Access Criteria: Individual participant data can be shared if the principal investigator is contacted.

Locations

TU (1)