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

NCT07365722 | Not Yet Recruiting

• 1 other identifier: 51376
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

peri implantitis

Outcome Measures

Primary Outcomes (1)

• Probing Pocket depth

  measure in mm of distance between gingival margin and bottom of the periodontal pocket

  12 months

Secondary Outcomes (2)

• Bleeding on probing

  12 months

• suppuration

  12 months

Study Arms (2)

Non Surgical Periodontal Therapy- Group

ACTIVE COMPARATOR

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: Non-Surgical Periodontal treatment (NSPT)

Minimally-invasive non-surgical therapy of peri-implantitis- Group

EXPERIMENTAL

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 pock

Procedure: Minimally-invasive non-surgical therapy of peri-implantitis

Interventions

Non-Surgical Periodontal treatment (NSPT) PROCEDURE

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.

Non Surgical Periodontal Therapy- Group

Minimally-invasive non-surgical therapy of peri-implantitis PROCEDURE

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

Minimally-invasive non-surgical therapy of peri-implantitis- Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of peri-implantitis (any implant surface/any amount of keratinized gingiva)
• PPD\>6mm at least in one implant surface
• Bone levels ≥3mm apical of the most coronal portion of the intra-osseous part of the implant.
• Implant surface deemed accessible by the treating clinician, without the need to remove the prosthetic suprastructure
• Full-mouth plaque score \<30%
• Full-mouth bleeding score \<30%

You may not qualify if:

• A course of antibiotics within the past 3 months
• Pregnant/lactating women
• Relevant medical history as evaluated by the examining clinician which may have the potential to affect periodontal surgical treatment (e.g., uncontrolled diabetes HbA1c≥7).
• Individuals on long-standing (2 or above years) supportive peri-implant care (SPIC)
• Previous non-surgical or surgical therapy of the affected implant within 12 months
• Current smoking or vaping (defined as any smoking or vaping within 12 months)
• Implant considered hopeless according to the treating clinician (e.g. mobility, circumferential bone loss \>80%, implant outside the bone envelope)
• Case needing adjunctive antibiotic therapy, according to the treating clinician

Sponsors & Collaborators

• King's College London: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Luigi Nibali, Chief Investigator

CONTACT

86824; luigi.nibali@kcl.ac.uk

Pasquale Santamaria, Study coordinator

CONTACT

07754680573; pasquale.santamaria@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation lists for each centre will be generated by an independent researcher, who will be involved in the study. The examiners, who assess the clinical variables, will be blinded with regards to the patients' treatment assignments. The measures will include no access to the dental records as to which treatment has been assigned and no access to the patients' treatment file. The statistician who will perform the statistical analyses, will have no access to the allocation of the patients into the respective treatment group. The clinician cannot be blinded since she/he has to handle the different devices, but she/he will have no access to the data collection sheets or the group allocation. The assistant to the clinician cannot be blinded since she/he has to handle the different devices, but she/he will have no access to the data collection sheets or the group allocation. The patients will be not blinded to the treatment provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): February 7, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE