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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dental Implant Failed; Alveolar Bone Loss; Platelet-rich Fibrin; Alveolar Rege Preservation
• Intervention / Treatment: Device: Dental implant

• Study Type: Observational

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20551-030
    • Rio de Janeiro State University
  • Rio De Janeiro, Brazil
    • Rio de Janeiro State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study presents the 1,3 and 5-year evaluation of a previously accomplished randomized, clinical study initiated in 2018. The study sample was recruited among patients referred to the School of Dentistry, University of Rio de Janeiro, Brazil for treatment with single-tooth implants.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Leucocyte- and Platelet-rich Fibrin; Dental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin	Device: Dental implant; A single dental implant was inserted 3 months after tooth extraction
Control; Dental implant placed into non-preserved post-extraction sites	Device: Dental implant; A single dental implant was inserted 3 months after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	1 year
Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	3 years
Marginal Bone Loss	Periapical digital radiographs will be used to make the measurements and evaluations.	5 years
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 72596717.3.0000.5259/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No