Clinical trial NCT03715439: Evaluation of Dental Implants Placed in Preserved and Non-preserved Post-extraction Ridges
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dental Implant Failed
Platelet-rich Fibrin
Alveolar Rege Preservation
Alveolar Bone Loss
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: survival rates of the implants
timeFrame: 1 year
measure: survival rates of the implants
timeFrame: 3 years
measure: survival rates of the implants
timeFrame: 5 years
measure: success rates of the implants
timeFrame: 1 year
measure: success rates of the implants
timeFrame: 3 years
measure: success rates of the implants
timeFrame: 5 years
Secondary outcomes:
measure: Marginal Bone Loss
timeFrame: 1 year
measure: Marginal Bone Loss
timeFrame: 3 years
measure: Marginal Bone Loss
timeFrame: 5 years
measure: Pink Esthetic Score
timeFrame: 1 year
measure: Pink Esthetic Score
timeFrame: 3 years
measure: Pink Esthetic Score
timeFrame: 5 years
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 5 years
measure: Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
timeFrame: 1 year
measure: Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
timeFrame: 3 years
measure: Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Rio de Janeiro State University
city: Rio De Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
References: