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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Dental implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leucocyte- and Platelet-rich Fibrin<br>Dental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin | Device: Dental implant<br>* A single dental implant was inserted 3 months after tooth extraction<br>|
| Control<br>Dental implant placed into non-preserved post-extraction sites | Device: Dental implant<br>* A single dental implant was inserted 3 months after tooth extraction<br>|

What is the study measuring?
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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 |