Study Overview (Design) This is a research study being carried out at several dental clinics to test two different types of non-surgical treatments for periimplantitis- a condition where the tissues around a dental implant become infected and inflamed. The goal is to see which treatment works better over a period of 12 months. Study Schedule Participants will be followed for 1 year after their treatment, with several check-up visits to monitor progress and collect information.
Who Can Take Part? Inclusion (Who can join?) People with peri-implantitis, a condition affecting the gums and bone around a dental implant.
At least one area around the implant with deep pockets (>6mm) and some bone loss.
Page 8 of 23 Project ID: 51376 Implants must be accessible for cleaning without removing the crown or prosthetic.
Good general mouth hygiene (low plaque and bleeding scores). Exclusion (Who cannot join?) People who recently took antibiotics. Pregnant or breastfeeding women. Those with certain medical conditions (e.g., uncontrolled diabetes). People who already had treatment for this condition recently. Smokers or people who vape. Implants that are severely damaged or considered untreatable. Recruiting Patients Patients referred to specialist periodontal clinics will be checked to see if they qualify. If they do, they'll be informed about the study and can decide whether to participate. If they agree, they will attend a baseline appointment where their current oral health will be recorded. Randomisation (Choosing Treatment Groups)
Participants will be randomly assigned to one of two treatment groups:
Standard non-surgical treatment Minimally invasive non-surgical treatment (MINST) The method of choosing who goes into which group is like flipping a coin-but controlled by a secure computer system to ensure fairness. Blinding/Masking (Avoiding Bias) The dentist doing the treatment will know which method is being used (they have to, to apply the treatment correctly).
But the person who checks the results (examiner) and the person analyzing the data (statistician) won't know who received which treatment. This helps make the study results more reliable. Patients will know which treatment they received. Treatment and Follow-up Visits
Participants will attend up to 7 visits over 12 months:
Visit 1 (Day 0 - Baseline) Consent to take part Full dental and medical check Photos taken Oral hygiene advice Visit 2 (Treatment)
One of the two types of cleaning will be performed:
Standard: Cleaning using ultrasonic tools and curettes. MINST: Cleaning using finer tools and magnification for a more gentle and precise approach.
Visit 3 (1 Month) Follow-up with oral hygiene support Check for pain or discomfort Short cleaning if needed Visit 4 (3 Months) - Optional Check-up with hygiene instructions Visit 5 (6 Months) Page 9 of 23 Project ID: 51376 Full periodontal check Cleaning and photos Visit 6 (9 Months) - Optional Same as 6-month visit Visit 7 (12 Months) Final check-up with full periodontal exam and photos Study completed Rescue Treatment (If Needed)
If the implant doesn't improve or worsens during the study, the patient may receive additional treatment, which could include:
Extra cleaning Surgery In serious cases, implant removal These situations will be documented and analyzed. Clinical Measurements
At various visits, the study team will:
Measure gum pocket depths around teeth and implants. Record bleeding, gum recession, plaque, and other oral health signs. Use a standard dental probe for measurements at six points around each implant and tooth.
Photographs Photos and sometimes videos will be taken to monitor changes over time. These will be stored securely and anonymised to protect patient privacy. PROMs (Patient-Reported Outcomes) Patients will fill in questionnaires at several time points (baseline, 4, 8, and 12 months) to report how their mouth condition affects their daily life. One is a general oral health quality-of-life questionnaire (OHIP-14), and another is implant-specific.
Repeatability (Calibration) To make sure the measurements are accurate and consistent, all examiners will go through training and calibration exercises before the study starts. X-rays Previous X-rays (taken within the last 3 months) will be used to confirm the bone loss around the implant. No new X-rays will be taken solely for the study. End of Study The study ends one year after the last patient finishes their follow-up. After that, patients can choose to be monitored annually for up to 4 more years.
