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Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.

U

University of Roma La Sapienza

Status

Completed

Conditions

Partially Edentulous Maxilla, Mandible

Treatments

Device: Microgrooved dental implants

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

20 participants in 2 patient groups

dental implants
Experimental group
Description:
microgrooved dental implants submerged
Treatment:
Device: Microgrooved dental implants
dentale implants
Experimental group
Description:
microgrooved dental implants nonsubmerged
Treatment:
Device: Microgrooved dental implants

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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