Evaluation of Dental Implants Placed in Preserved and Non-preserved Post-extraction Ridges

Alveolar Bone Loss Clinical Trial

Official title:

Evaluation of Dental Implants Placed in Preserved Post-extraction Ridges With Leucocyte- and Platelet-rich Fibrin: 1, 3 and 5-year Post-loading Outcome of a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03715439
• Other study ID #: 72596717.3.0000.5259/2
• Status: Withdrawn
• Start date: November 13, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2022
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective study to evaluate and compare implants placed in preserved versus non-preserved extraction sockets using L-PRF (Leucocyte- and platelet-rich fibrin) after 1, 3 and 5 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Health patients, American Society of Anesthesiologists (ASA) I or II

• Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth which present ideal conditions to receive dental implants after 3 months.

Exclusion Criteria:

• Systemic diseases related with healing disorders

• Poor oral hygiene

• Pregnant or lactating patient

• Use of flap elevation for dental extraction

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Rege Preservation
• Dental Implant Failed
• Platelet-rich Fibrin

Intervention

Device:
• Dental implant
A single dental implant was inserted 3 months after tooth extraction

Locations

Country	Name	City	State
Brazil	Rio de Janeiro State University	Rio De Janeiro
Brazil	Rio de Janeiro State University	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rates of the implants	The term surviving refers to those implants that are still in the jaw of the patient but either have not met success criteria or have not been tested for success.	1 year
Primary	survival rates of the implants	The term surviving refers to those implants that are still in the jaw of the patient but either have not met success criteria or have not been tested for success.	3 years
Primary	survival rates of the implants	The term surviving refers to those implants that are still in the jaw of the patient but either have not met success criteria or have not been tested for success.	5 years
Primary	success rates of the implants	Success is graded in three qualities, depending on the extent and results of performed examinations.; Grade 1.; Absence of mobility is checked by individual stability testing of the unattached implant.; Radiographic evaluation of each implant reveals not more than 1.0 mm of marginal bone loss during the first year of loading, followed by not more than 0.2 mm resorption per year.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.; Grade 2.; Radiographic evaluation; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.; Grade 3.; Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.	1 year
Primary	success rates of the implants	Success is graded in three qualities, depending on the extent and results of performed examinations.; Grade 1.; Absence of mobility is checked by individual stability testing of the unattached implant.; Radiographic evaluation of each implant reveals not more than 1.0 mm of marginal bone loss during the first year of loading, followed by not more than 0.2 mm resorption per year.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.; Grade 2.; Radiographic evaluation; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.; Grade 3.; Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.	3 years
Primary	success rates of the implants	Success is graded in three qualities, depending on the extent and results of performed examinations.; Grade 1.; Absence of mobility is checked by individual stability testing of the unattached implant.; Radiographic evaluation of each implant reveals not more than 1.0 mm of marginal bone loss during the first year of loading, followed by not more than 0.2 mm resorption per year.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.; Grade 2.; Radiographic evaluation; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.; Grade 3.; Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.; Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.	5 years
Secondary	Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	1 year
Secondary	Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	3 years
Secondary	Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	5 years
Secondary	Pink Esthetic Score	The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.	1 year
Secondary	Pink Esthetic Score	The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.	3 years
Secondary	Pink Esthetic Score	The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.	5 years
Secondary	Patient satisfaction - Questions will be scored on 100mm visual analog scales. The patients marked their response on a horizontal line for which the most negative expression corresponded to 0 and the most positive to 100.	Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?	1 year
Secondary	Patient satisfaction - Questions will be scored on 100mm visual analog scales. The patients marked their response on a horizontal line for which the most negative expression corresponded to 0 and the most positive to 100.	Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?	3 years
Secondary	Patient satisfaction - Questions will be scored on 100mm visual analog scales. The patients marked their response on a horizontal line for which the most negative expression corresponded to 0 and the most positive to 100.	Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?	5 years
Secondary	Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire	The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.	1 year
Secondary	Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire	The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.	3 years
Secondary	Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire	The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.	5 years