Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty

NCT06063876 | Enrolling By Invitation

• 1 other identifier: STUDY22060181
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with implantoplasty (IP) compared to those treated without IP.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Implantoplasty; Marginal bone level; Probing depth; Bleeding on probing

Outcome Measures

Primary Outcomes (1)

• Changes in the modified Gingival Index (mGI) between 21 and 42 days

  The mGI will be assessed according to the following criteria: Score 0 - No bleeding on probing; Score 1 - Bleeding dot; Score 2 - Continuous line of blood that fills the sulcus; Score 3 - Profuse bleeding and/or hemorrhage drip. Changes in the scores between day 21 and day 42 will be determined, being 0 minimum and 3 maximum. The mGI will be assessed weekly.

  At 21 and 42 days

Secondary Outcomes (5)

• modified Plaque Index (mPI)

  Up to 42 days

• Changes in probing depth (PD)

  Up to 42 days

• Marginal bone loss (MBL)

  From baseline to 42 days

• Peri-implant crevicular fluid (PICF) immunologic profile

  Up to 42 days

• Microbiological profile of the biofilm analysis

  Up to 42 days

Study Arms (1)

Implants with history of peri-implantitis

EXPERIMENTAL

Implant(s) treated previously for peri-implantitis with or without exposed polished surface, no PD \> 4 mm and \< 50% bone loss.

Procedure: Induction of experimental peri-implant mucositis; Procedure: Resolution of experimental peri-implant mucositis

Interventions

Induction of experimental peri-implant mucositis PROCEDURE

Patients will refrain from oral hygiene measures at the implant sites for 3 weeks to induce peri-implant mucositis, by using a stent in the included implant during oral hygiene.

Implants with history of peri-implantitis

Resolution of experimental peri-implant mucositis PROCEDURE

Patients will reinstitute oral hygiene measures, receive an oral prophylaxis and oral hygiene instructions and will be evaluated during 3 weeks.

Implants with history of peri-implantitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years
• In good general health, (at least ASA 2)
• Previously treated implants must have probing depths (PD) ≤ 4 mm
• Previously treated implants must have \<50% bone loss around the implant of interest (assessed radiographically)
• Patients must have been treated previously for peri-implantitis with or without IP, with at least 1 thread or 2 mm of implant surface exposed in the oral cavity.
• Have little to no bacteria on the implant(s) of interest (modified Plaque Index of \<1) by Day 0
• Have healthy gums that do not bleed around the implant(s) of choice (modified Gingival index \<1) by Day 0
• Have evidence of stable bone levels around the treated implant for \> 6 months

You may not qualify if:

• Active infectious diseases of any kind.
• Medical conditions which require premedication prior to dental treatments/visits.
• Pregnant women or planning to become pregnant (self-reported).
• Patients with congenital or metabolic bone disorders (ie. osteoporosis, vitamin D deficiency, parathyroid disease, etc.)
• Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset (self-reported)
• Subjects with co-morbid conditions (i.e., uncontrolled diabetes, cardiovascular disease, impaired kidney function, heart murmur, rheumatic fever, bleeding disorder, hepatitis, tuberculosis, HIV) that would affect the study outcome or interpretation of study results will be excluded.
• Concomitant medications: Subjects on significant concomitant drug therapy for systemic conditions (i.e., Chronic anti-inflammatory medication, antibiotics, anticoagulants, any medication initiated \<3 months prior to the screening visit) will not be included in the study. Occasional short-term use (7-14 days) of analgesics or common cold medication is permitted. Such use of these medications will be reviewed and recorded by the Investigator.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Ravida

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 3, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)