Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

University of Messina

Status: Completed

Conditions: Peri-implant Mucositis

Treatments: Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04751565

2021-18/18

Details and patient eligibility

About

This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Full description

Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

Enrollment: 54 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female aged > 18 years
• TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
• Implants placed in both arches
• Patients with gingivitis or treated periodontitis (i.e., absence of residual PD > 5 mm)
• Presence of at least 2 mm of keratinized mucosa at implant sites.

Exclusion criteria

• presence of medical conditions contraindicating treatment of peri-implant mucositis,

• regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment

  • Presence of systemic diseases
  • Pregnant and lactating females
  • Smokers > 10 cigarettes/day
  • Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  • Implants with modified (i.e. micro-rough) necks
  • Interproximal open contacts between implant restoration and adjacent teeth
  • Peri-implantitis (Renvert, et al., 2018)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Tissue level implant Group

Experimental group

Description:

Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant Primary outcome The primary outcome will be based on probing depth (PD)

Treatment:

Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Bone level implant Group

Experimental group

Description:

Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant Primary outcome The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).

Treatment:

Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy