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

Peri-implant Mucositis Clinical Trial

Official title:

Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751565
• Other study ID #: 2021-18/18
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2023
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 20, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Other:
• Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pocket probing depth (PD) mm changes	changes in Pocket probing depth (PD)	Baseline (T0), 3-months (T1) and at 6-months (T2)
Other	Presence of plaque at implant sites according to plaque index (PlI)	Changes in presence of plaque at implant sites according to plaque index (PlI)	Baseline (T0), 3-months (T1) and at 6-months (T2)
Primary	Bleeding on Probing (BOP) changes	Changes over time in BOP changes (percentage)	Baseline (T0), 3-months (T1) and at 6-months (T2)
Secondary	Full mouth plaque score (FMPS) changes	Chenges in Full mouth plaque score (FMPS) (parameter)	Baseline (T0), 3-months (T1) and at 6-months (T2)