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Completed

NCT Number: NCT06915623

Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is:

Does the gel reduce gum bleeding?

Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application.

The study process includes the following steps:

1. Participants will visit the clinic and receive one of the two treatments randomly. 2. One week later, they will complete a printed survey detailing any symptoms or discomfort experienced . 3. After four weeks, participants will return to the clinic for checkups and tests to measure progress.

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Key information

Conditions

Peri-implant Mucositis Healthy Peri-implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculté de Médecine dentaire de l'Université Laval

Québec, Quebec, G1V 0A6, Canada

About this study

This clinical study, conducted at Laval University's graduate periodontics clinic, investigates the efficacy and safety of a nanocrystal gel as a supplementary treatment to non-surgical mechanical debridement (professional cleaning) for managing peri-implant mucositis-a reversible inflammatory condition affecting the soft tissues around dental implants. The study enrolls eight participants, comprising individuals with either healthy peri-implant tissues or peri-implant mucositis. Participants are randomly assigned to one of two groups: the test group receives the nanocrystal gel in conjunction with standard peri-implant therapy, while the control group undergoes peri-implant therapy alone.

The primary focus of the investigation is the bleeding on probing (BoP) parameter, analyzing its progression over a four-week period and comparing outcomes between the two groups. Additionally, other clinical parameters, including the modified gingival index, modified plaque index, and pocket depth, are evaluated.

Participants receive one of the designated treatments, with the study design ensuring they are blinded to the specific treatment administered. A follow-up appointment four weeks later allows for the reassessment of all recorded clinical parameters. One week after treatment, participants complete a survey to report any discomfort or pain experienced post-treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 or older
  • Maxillary or mandibular fixed implant-supported prostheses (up to 3 units)
  • Diagnosis of peri-implant health or peri-implant mucositis
  • Signed an informed consent form

Exclusion criteria

  • Advanced peri-implantitis
  • Extensive implant-supported restorations (four units or more)
  • Recent radiotherapy, chemotherapy, long-term systemic corticosteroid therapy
  • Drugs inducing gingival hyperplasia
  • Recent antibiotics (within three months)
  • Prosthetic restorations impeding clinical assessment
  • Poor marginal contours or prosthetic complications
  • Peri-implant bone loss exceeding 30%
  • Acute oral infection
  • Uncontrolled diabetes, systemic diseases, immune deficiency, autoimmune disease
  • Long-term bisphosphonate use

Treatment and study plan

Innovative Gel application

Drug

Innovative gel application: Gel is applied as an adjunct treatment to cleaning and scaling.

Mechanical debridement

Procedure

Cleaning and scaling of the implant.

Primary outcomes

  1. Bleeding on probing (BOP)

    Time frame: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.

    A periodontal probe is gently inserted into the sulcus (the space between the implant and the surrounding gum tissue). The probe is moved around the implant in a sweeping motion, covering all surfaces (Mesial, Distal, Buccal and Palatal/Lingual). This gesture is done with light pressure to avoid causing unnecessary trauma to the tissues. After probing, the clinician observes the site for any bleeding. Bleeding that occurs within 10 to 15 seconds after probing is recorded as a positive BOP result.

Secondary outcomes

  1. Plaque index (PI)

    Time frame: It is assessed on intervention day and at a 4 week- follow up appointment

    The plaque index is calculated by assigning a score to each surface based on the presence of plaque present, after probing. It is registered on the Mesial, Distal, buccal and palatal/lingual sides of the implant. Scores are reported dichotomously. It categorizes plaque as either present or absent, using a binary scoring system:

    1: Presence of plaque 0: Absence of plaque A higher overall plaque score could indicate a worse outcome with a higher risk of inflammation of the tissues surrounding the implant.

  2. Modified Gingival Index (MGI)

    Time frame: It is assessed on intervention day and at a 4 week- follow up appointment

    The testing was made similarly to the bleeding on probing, but also takes into consideration the visual evaluation of the tissues around the implant. The clinician focuses on detecting visual signs of inflammation, such as redness, swelling, and altered gingival contour. It is tested on the mesial, distal, buccal and palatal/lingual sides of the implant. Results are reported from a 0 to 4 scale with 0 indicating no bleeding and 4 indicating extreme inflammation with ulceration and tissue damage.

  3. Probing Depth

    Time frame: It is assessed on intervention day and at a 4 week- follow up appointment

    It is measured using a UNC15 periodontal probe. It is gently inserted into the sulcus or pocket surrounding the implant, following the contours of the implant and tissue. Care is taken to avoid excessive pressure, which could damage the delicate peri-implant tissue or lead to inaccurate readings. It is assessed at the mesial, distal, buccal and palatal/lingual sides.

Other outcomes

  1. Suppuration

    Time frame: It's assessed at the 4 week follow-up appointment.

    Presence or Absence were noted (qualitatively) 15 seconds after probing test.

  2. Irritation, Pain and Discomfort

    Time frame: This was reported at 7 days post-op.

    These are subjective outcomes reported by the patient by a questionnaire sent to them. Patients have to indicate from a scale of 0 to 10 :

    • Discomfort (0 is no discomfort and 10 is the worst discomfort)
    • Irritation (0 is no irritation and 10 is the worst irritation)
    • Pain (0 is no pain and 10 is the worst pain)

Sponsors and collaborators

Lead sponsor

Nancy Mouradian

Other

Collaborators

  • Invicare Inc.

Registry information

Official study title

Nanocrystal Gels to Treat and Prevent Peri-implant Mucositis: A Randomized Controlled Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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