Clinical trial NCT03686865: Peri-implant Marginal Bone and Soft Tissue Conditions Around Single Laser-Lok Implants Placed in Regenerated Extraction Sockets and in Native Bone: A 2-years Results of RCT
Official title: Peri-implant Marginal Bone and Soft Tissue Conditions Around Single Laser-Lok Implants Placed in Regenerated Extraction Sockets and in Native Bone: A 2-years Results of RCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partially Edentulous Maxilla, Partially Edentulous Mandible
Keywords: regenerated bone, native bone, dental implant
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with monoedentulism

Brief summary: The aim of present study was to compare peri-implant marginal bone loss and soft tissues conditions around single Laser-Lok implants placed in alveolar

Detailed description: Records of 20 consecutive patients treated with dental implants placed in post-extraction sockets augmented with porcine derived bone and 20 consecutive patients with implants placed in native bone were reviewed. For each implant, the radio- graphs from the surgical appointment were compared to those from the last follow-up visit and evaluated regarding changes of marginal bone level over time.

Eligibility criteria: Inclusion Criteria:

* mono-edentulism, age ≥ 18 years, good general health, without contraindications to implant surgery

Exclusion Criteria:

* lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (\> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) ≥25%, teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.

Primary outcomes:
measure: peri-implant marginal bone loss
timeFrame: 2 years
Secondary outcomes:
measure: peri-implant soft tissue conditions
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Universita la Sapienza
Study officials:
References:
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