Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05595746
Other study ID # 2020-05/07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date March 9, 2023

Study information

Verified date November 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 9, 2023
Est. primary completion date March 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - >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 Exclusion Criteria: - 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

Study Design


Intervention

Procedure:
dental implant placement
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.

Locations

Country Name City State
Turkey Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Marginal bone loss related keratinized gingival height Peri-implant marginal bone loss with keratinized gingival height 1 year after prosthetic loading
Secondary Marginal bone loss related keratinized gingival thickness Peri-implant marginal bone loss with keratinized gingival thickness 1 year after prosthetic loading
Secondary Evaluation of clinical peri-implant health with plaque index Peri-implant plaque index clinical data will be used. 1 year after prosthetic loading
Secondary Evaluation of clinical peri-implant health with gingival index Peri-implant gingival index clinical data will be used. 1 year after prosthetic loading
Secondary Evaluation of clinical peri-implant health with bleeding on probing index Peri-implant bleeding on probing clinical data will be used. 1 year after prosthetic loading
Secondary Evaluation of clinical peri-implant health with pocket depth on probing index Peri-implant pocket depth on probing clinical data will be used. 1 year after prosthetic loading
See also
  Status Clinical Trial Phase
Completed NCT05332327 - Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Enrolling by invitation NCT06063876 - Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty N/A
Completed NCT04249024 - Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery N/A
Withdrawn NCT03624257 - Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery N/A
Completed NCT03157193 - Effect of Hyaluronic Acid on Perimplantitis Phase 4
Completed NCT03018795 - Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis N/A
Completed NCT02375750 - Treatment of Peri-implantitis Lesions by Using Biomaterial N/A
Enrolling by invitation NCT02575274 - Peri-Implantitis Surgical Treatment an RCT Study Phase 2/Phase 3
Completed NCT04833569 - ICG-PDT, Periimplantitis, Diabetes Mellitus Phase 1
Not yet recruiting NCT04337645 - Resective Surgical Treatment of Peri-implantitis. N/A
Enrolling by invitation NCT06033859 - Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
Active, not recruiting NCT06390124 - Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21) Phase 4
Enrolling by invitation NCT05675241 - Characterizing the Inflammation Around Dental Implants
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Not yet recruiting NCT04323540 - Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation N/A
Completed NCT04769609 - Reconstructive Surgical Therapy of Peri-implantitis
Completed NCT04874467 - Influence of Keratinized Mucosa on Dental Implants With Mucositis N/A
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT04559841 - Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin N/A
Recruiting NCT05906810 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis N/A