Natural Bioactive Gel for Peri-Implantitis

The Modified Plaque Index (mPI) is a semi-quantitative index used to assess the presence and accumulation of bacterial plaque around dental implants. Scores are recorded at six peri-implant sites per implant using a 3-point scale, where 0 indicates no plaque, 1 indicates plaque detectable only with a probe, and 2 indicates plaque visible to the naked eye. For each implant, the mean score is calculated. At the patient level, the percentage of sites with a score greater than or equal to 1 is also calculated. The primary outcome is the change in mPI between baseline and the final follow-up, comparing treated and control sites.

Bleeding on Probing (BoP) is a binary clinical index used to assess inflammation of peri-implant soft tissues. Six peri-implant sites are evaluated per implant. Each site is scored as 0 if no bleeding occurs within 15 seconds of gentle probing, or 1 if bleeding is present. The percentage of bleeding sites is calculated for each patient. The outcome is the change in the percentage of peri-implant sites with BoP ≥1 over time, comparing test and control sites.

The Bleeding Score (BS) assesses bleeding severity upon probing at six sites per implant. Each site is scored on a 4-point scale: 0 = no bleeding, 1 = isolated bleeding points, 2 = continuous bleeding line along the margin, 3 = profuse bleeding. The outcome is the change in the mean BS and the percentage of sites with BS ≥1 over time, calculated at the patient level.

Probing Depth (PD) is measured at six sites per implant using a calibrated periodontal probe with light force (≤ 0.25 N). It represents the distance in millimeters from the mucosal margin to the base of the pocket. The outcome is the change in mean PD per implant and the percentage of sites with PD ≥4 mm, calculated at the patient level over time.

Suppuration Index (SI) evaluates the presence of purulent exudate at four peri-implant sites per implant (mesial, distal, buccal, lingual/palatal). Each site is scored as 0 (no suppuration) or 1 (visible suppuration upon probing). The outcome is the change over time in the percentage of sites with suppuration, calculated at the patient level.

Implant mobility is assessed manually using two rigid instruments. The score is assigned as follows: 0 = no mobility, 1 = perceptible horizontal mobility on manual testing, 2 = clinically visible horizontal mobility, 3 = horizontal and vertical mobility (indication for implant removal). The outcome is the change in implant mobility score over time, evaluated per implant.

The Gingival Bleeding Index (GBI) assesses marginal gingival inflammation. Four sites per implant (mesial, distal, buccal, lingual/palatal) are gently probed. A score of 1 indicates bleeding within 10-15 seconds; 0 indicates absence of bleeding. The outcome is the change in the percentage of sites with GBI = 1 at the patient level over time.

Marginal Mucosal Conditions (MMC) assess visible signs of inflammation (redness, edema, altered contour) at four peri-implant sites. Each site is scored as 0 (healthy mucosa) or 1 (clinical signs of inflammation). The outcome is the change in the percentage of sites with MMC = 1 at the patient level over time.

Mucosal Margin Migration (MMM) assesses the presence of apical migration of the mucosal margin compared to baseline. Four sites per implant are examined visually. A score of 0 indicates no migration; 1 indicates visible apical shift. The outcome is the change in the percentage of sites with MMM = 1 at the patient level over time.

Radiographic Bone Loss (RBL) is a quantitative parameter used to assess marginal bone loss around dental implants. Standardized intraoral radiographs are obtained using a Rinn-type centering device. For each implant, the distance in millimeters from the implant shoulder to the first visible bone-to-implant contact is measured both mesially and distally. Bone loss is recorded in absolute millimeters and expressed as a percentage of the total implant length. The outcome is the change in mesial and distal RBL values between timepoints, comparing test and control sites.