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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Crown modification

    Procedure/Surgery

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

mBI long term

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

Time frame
12 months following treatment
2

mBI short term

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

Time frame
60-70 days following treatment
3

residual plaque and calculus

% of plaque and calculus on the subgingival surface of crown

Time frame
baseline

Secondary outcomes

1

PI long term

plaque index (PI) around implant long term

Time frame
12 months following treatment
2

PD short term

probing depth (PD) around implant short term

Time frame
60-70 days following treatment
3

PD long term

probing depth (PD) around implant long term

Time frame
12 months following treatment
4

PI short term

plaque index (PI) around implant short term

Time frame
60-70 days following treatment

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: