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OpenTrials
Completed

NCT Number: NCT03674762

Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.

Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universita la Sapienza

Roma, 00100, Italy

About this study

Materials and methods: 20 submerged/two-stage implants and 20 nonsubmerged/one stage implants were placed randomly with a split mouth design, in 20 partially edentulous patients. Radiographic and clinical examinations were carried out at the implant placement (Baseline, BSL), at the delivery of prosthetic restorations (T0), and at each year of the follow-up period (T1, T2, T3). Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and gingival recession (REC) were recorded. Radiographic marginal bone levels (MBL) were assessed at the mesial (MI) and distal (DI) aspect of implant sites. In addition, the influence of keratinized tissue thickness (KTT) on MBL was investigated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla.

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Exclusion criteria

  • Exclusion criteria were: implants placed into regenerated bone, 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%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.

Treatment and study plan

Microgrooved dental implants

Device

Dental Implant placement

Primary outcomes

  1. radiographic marginal bone loss

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Submerged vs. Nonsubmerged Single Laser-microgrooved Implants. Clinical and Radiographic Results at 3-years of RCT With Split Mouth Design.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2018
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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