Effectiveness of Zirconia Glaze Removal and Polish in the Treatment of Peri-implant Mucositis

NCT06619158 | Not Yet Recruiting

• 1 other identifier: H2024:048
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold standard treatment of non-surgical cleanings and oral hygiene instructions. The purpose of the study is to compare the effect of crown glaze removal and subsequent polishing in addition to mechanical debridement compared to only mechanical debridement on the implant affected by implant gum inflammation. In this study, participants will be randomized (put into a group by chance) into one of 2 study groups, groups A and B. Group A: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician who will remove the glaze and polish the crown only in the areas that sit under the gums. Group B: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician to perform a superficial cleaning only. In both groups, the crown will be placed back on the implant and customized oral hygiene instructions will be provided. The study will require four appointment. Appointment #1 is the screening appointment and will take 30-60 minutes. Appointment #2 is when treatment is delivered and will occur within 4 weeks of appointment #1. Appointment #3 is for the short-term follow-up and will occur within 60-70 days of appointment #2. Appointment #4 is for the long-term follow-up and will occur within 12-13 months of appointment #2. All these appointment will be in an outpatient setting at the institutional graduate periodontics clinic. A total of 2 x-rays will be taken of the implant. One will be taken during appointment #1 to assess the bone around the implant. One will be taken during appointment #2 to ensure that the crown is fully seated when the crown is re-inserted. The following information will be collected in appointment #1: gum measurements around the implants, how tight the implant contacts adjacent teeth, when the crown was delivered, previous cleanings around the implant, age, sex, gender, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values. At appointments #2, 3, and 4, the following information will be collected: plaque around implant, gum measurements around implants, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values, gum fluid samples around the implant crown. In appointment #4, additionally, information on how the implant has been cleaned throughout the year will be collected.

Conditions

Peri-Implantitis and Peri-implant Mucositis

Keywords

zirconia glaze removal, crown modification

Outcome Measures

Primary Outcomes (3)

• mBI long term

  modified Bleeding index (mBI) around the implant long term (12 months following treatment)

  12 months following treatment

• mBI short term

  modified bleeding index (mBI) around the implant short term (60-70 days following treatment)

  60-70 days following treatment

• residual plaque and calculus

  % of plaque and calculus on the subgingival surface of crown

  baseline

Secondary Outcomes (28)

• PI long term

  12 months following treatment

• PD short term

  60-70 days following treatment

• PD long term

  12 months following treatment

• PI short term

  60-70 days following treatment

• IL-1β baseline

  baseline

Study Arms (2)

Group A

EXPERIMENTAL

Crown modification with glaze removal and polish of implant crown

Procedure: Crown modification

Group B

NO INTERVENTION

No intervention will be applied. The crown will be removed and superficially cleaned

Interventions

Crown modification PROCEDURE

Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 1 single screw-retained zirconia glazed implant crown which is in function for at least 1 year, with adequate contact points, submucosal crown margins, no adjacent implants, adequate keratinized tissue (2mm or more), and peri-implant mucositis that persists despite recent (within the past 6 months) non-surgical debridement

You may not qualify if:

• Contraindications to routine dental treatment Open interproximal contacts, splinted implant prosthesis, peri-implant health, peri-implantitis, cemented crown , removable implant prosthesis, recession past the implant platform Systemic antibiotic use within the last 2 weeks heavy smokers (more than 10 cigarettes/day) uncontrolled diabetes (HbA1C more than 7.0%)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Dr Sam Borden Periodontology Specialty Clinic

Winnipeg, Manitoba, R3E 0W2, Canada

Location

Related Publications (21)

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MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Chrysi Stavropoulou, DDS, MDent(Perio)

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrysi Stavropoulou, DDS, MDent(Perio)

CONTACT

204-272-3075; chrysi.stavropoulou@umanitoba.ca

Daniel Su, DMD

CONTACT

2047893426; sud4@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CA (1)