Comparison of Two Non-surgical Procedure to Manage Gum Disease Around Implants.

Summary

Research Question:

Can a minimally invasive, non-surgical treatment approach (MINST) be more effective than the current standard non-surgical method in treating peri-implantitis, a common inflammatory condition affecting dental implants?

Background:

Dental implants are widely used to replace missing teeth. While they are usually successful, some patients develop a condition called peri-implantitis, an infection that causes inflammation and bone loss around the implant. This can eventually lead to implant failure if not treated properly. Currently, non-surgical treatments are used to clean the area and reduce inflammation. However, these methods often fall short of fully resolving the issue, and many patients require further treatment or even surgery.

A newer approach called MINST (Minimally-Invasive Non-Surgical Therapy) has shown promising results for treating gum disease around natural teeth. This method focuses on precision cleaning with minimal trauma to the surrounding tissues, reducing pain and improving healing. While MINST works well for gum disease, its effectiveness for treating peri-implantitis has not yet been tested.

Purpose of the Study:

This clinical trial will compare the effectiveness of MINST with the standard non-surgical treatment currently used for peri-implantitis.

The aim is to determine whether MINST can better treat the disease, improve healing, and reduce discomfort for patients.

Hypotheses:

Alternate Hypothesis (What we expect to find): MINST will result in better outcomes, specifically, fewer deep pockets around the implant, less bleeding, and fewer signs of infection, compared to the standard treatment.

Null Hypothesis: There will be no significant difference between the outcomes of the two treatment approaches.

Study Design:

Type of Study: A randomized controlled trial (RCT) involving 106 patients. Duration: Patients will be followed for 12 months after treatment. Locations: Multiple dental centers participating in the trial. Method: Half of the participants will receive MINST; the other half will receive the standard treatment. Neither patients nor outcome assessors will know which treatment was used (single-masked). What Will Be Measured? Primary Goal: To see how many patients show healing (defined as smaller pockets, little or no bleeding, and no pus) 12 months after treatment.

Secondary Goals:

Patient-reported outcomes, including pain levels and quality of life Changes in pocket depth and tissue attachment Bacterial changes Time taken for treatment appointments Why Is This Important? If MINST proves to be more effective and comfortable for patients, it could change how peri-implantitis is managed in the future- potentially reducing the need for surgery, improving patient experience, and helping more people keep their dental implants for longer.

Conditions

• Peri Implantitis

Interventions

PROCEDURE

Non-Surgical Periodontal treatment (NSPT)

Control group will receive one session of non-surgical debridement as described previously (Liñares et al., 2019) by an experienced periodontist. Non-surgical treatment under local anaesthesia consisting of supra- and submucosal mechanical debridement using ultrasonic stainless steel scaling inserts(EMS® , Electro Medical Systems) will be performed in one treatment session with no time restrictions. After that, a stainless steel Columbia 4R/4L curette (LM Instruments Oy) will be used to remove granulation tissue and minor mucosal curettage.

PROCEDURE

Minimally-invasive non-surgical therapy of peri-implantitis

Half of the study participants (tests) will be randomised to receive minimally-invasive non-surgical periodontal treatment (MINST). All treatment will be carried out by the same therapist in each centre, including oral hygiene. The protocol for MINST is as follows: participants will receive local anaesthesia, then thorough debridement of the implant surface will be completed to the depth of the periodontal and peri-implant pockets following this protocol: * In agreement with (Mehta et al., 2024) exclusive use of piezo-electric/ultrasonic devices with specific non-diamond thin and delicate tips (PS, PL1, PL2 from EMS, Nyon, Switzerland; Siroperio 1, 2, 3 and 7 from Sirona, Salzburg, Austria; Woodpecker P3 tip, Guilin Woodpecker, Guilin, China; Satelec 10Z from Acteon, UK, depending on what was available in the different study centres) * using at least x3 magnification loupes * aiming to obtain a stable blood clot in the pocke

Sponsors & Collaborators

• King's College London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-01-31

Completion

2028-02-07