Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects

実験的：Intervention

Arm 1

手順：minimally invasive non-surgical therapy

non-surgical periodontal therapy using minimally invasive approach

アクティブコンパレータ：Control

arm 2

手順：minimally invasive periodontal surgery

Single flap approach

CAL gain

Clinical attachment level (CAL) gain - Clinical examinations using UNC-15 Periodontal probe at baseline, 3 months and 6 months postoperatively.

CAL will be measured in millimeters from the CEJ to the bottom of the gingival sulcus/periodontal pocket at six sites per tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual surfaces.

*Higher scores (mm) indicate worse outcome.

Radiographic defect depth reduction (RDR)

The depth of intrabony defect will be measured from the alveolar bone crest to the base of the defect at baseline and after 6 months to detect the amount of bone fill using cone beam computed tomography (CBCT).

Plaque index

Presence of dental plaque will be recorded at baseline, 3 months, and 6 months via clinical examination using UNC-15 periodontal probe. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3 (Löe, 1967). The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria:

Score 0: No plaque Score 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

Score 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.

Score 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

*Higher scores indicate worse outcome.

Bleeding on Probing

Clinical examination using UNC-15 Periodontal probe at baseline, 3 months and 6 months postoperatively.

Gentle probing of the orifice of the gingival crevice will be done, with the periodontal probe inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded (Ainamo and Bay, 1975).

*Positive finding indicates worse outcome.

Pocket depth (PD) reduction

Clinical examination using UNC-15 Periodontal probe at baseline, 3 months and 6 months postoperatively.

PD will be measured in millimeters from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket at six sites per tooth.

*Higher scores (mm) indicate worse outcome.

Chair time

Measuring the time of procedure using Stopwatch Time spent in both treatment groups will be calculated using a stopwatch, and the total duration a patient spends undergoing the active treatment procedure will be measured from the moment the procedure begins until it ends (Aimetti et. al., 2017).

Healing

Evaluating wound healing following procedure using "Early Wound Healing Index (EWHI)" that will assess flap healing at 1 and 8 weeks postoperative using a 5-point scale based on Wachtel et al. (2003). EWHI will be scored as follows:

Score 1: Complete flap closure with no fibrin line in the interproximal area Score 2: Complete flap closure with a fine fibrin line Score 3: Complete flap closure with a fibrin clot Score 4: Incomplete flap closure with partial necrosis of the interproximal tissue Score 5: Incomplete flap closure with complete necrosis of the interproximal tissue.

*Higher scores mean a worse outcome (score 1 is the best outcome while score 5 is the worst outcome).

Oral health-related quality of life

The shorter Oral Health Impact Profile (OHIP-14) version will be used 1 week postoperatively. It measures the seven dimensions of oral health related-quality of life: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Each dimension is assessed in two questions. The response for each item will be recorded in a five-point scale with 0=never, 1=hardly ever, 2=occasionally, 3=fairly often and 4=very often. Within each 12 dimension, the response is multiplied by preset weights to calculate each subscore analysis (Slade, 1997).

*Higher scores indicate worse quality of life.

Cost effectiveness

Cost effectiveness analysis via calculation of ICER (Incremental Cost-Effectiveness Ratio) will be done 6 months postoperatively

Visual Analog Scale (VAS) pain score

A Visual Analog Scale (VAS) will be used to measure postoperative pain following periodontal treatment. The scale will consist of a horizontal line numbered from 0 to 10, where 0 will indicate no pain and 10 will indicate the most intense pain (higher scores indicate worse outcome). Patients will be instructed to mark their pain level on the VAS sheet 1 week postoperatively. Pain intensity will be categorized as follows: 0 = no pain, 1-4 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain (Price et al., 1983).

Post-operative patient satisfaction

Overall treatment satisfaction will be evaluated at the 6-month follow-up using a binary outcome (yes/no) response to the question of whether the participant would choose to undergo the same surgical procedure again, based on their perception of the treatment outcome and postoperative pain (Balice et al., 2024).