Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05592821
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2022-10-20
Brief Title:
Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants Two-piece Abutment Concept
Sponsor:
Berceste Guler
Organization:
Kutahya Health Sciences University
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants Two-piece Abutment Concept
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsThe 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
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 patients 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 patientsThe 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 patients 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 008 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 005 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
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 patientsThe 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 patients 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 008 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None