Periodontitis, Periodontitis (Stage 3)
Conditions
Keywords
Periodontitis, Stage III Periodontitis, Stage IV Periodontitis, Minimally Invasive Non-Surgical Therapy, MINST, Scaling and Root Planing, Root Debridement
Brief summary
This single-center, split-mouth, randomized controlled clinical trial aims to evaluate the clinical effectiveness of Minimally Invasive Non-Surgical Therapy (MINST) as an adjunct to conventional non-surgical periodontal therapy in patients with Stage III/IV periodontitis. Twenty-three systemically healthy adults presenting with bilateral molar teeth exhibiting periodontal pockets ≥5 mm with bleeding on probing will be enrolled. In each participant, molar teeth will be randomly allocated to receive either conventional subgingival scaling and root planing (SRP) using ultrasonic instruments alone (control) or conventional SRP followed by MINST using Mini-Five Gracey curettes under magnification loupes (test). Clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), will be evaluated at baseline, 3 months, and 6 months after treatment. The study will investigate whether MINST provides superior clinical outcomes compared with conventional non-surgical periodontal therapy.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues. Conventional non-surgical periodontal therapy based on scaling and root planing (SRP) is considered the first-line treatment for periodontal pockets. However, complete removal of subgingival biofilm and calculus may be difficult in deep pockets, furcation areas, and root concavities because of limited access. Minimally Invasive Non-Surgical Therapy (MINST) has been introduced to improve access to deep periodontal defects while minimizing soft tissue trauma. The technique combines magnification loupes with Mini-Five Gracey curettes to allow more precise instrumentation and preservation of soft tissues during periodontal debridement. This prospective, single-center, split-mouth randomized controlled clinical trial will include 23 patients diagnosed with Stage III/IV periodontitis. Bilateral molar teeth with probing pocket depth ≥5 mm and bleeding on probing will be randomly assigned to either the test or control intervention within each participant. The control sites will receive conventional subgingival scaling and root planing using ultrasonic instruments. The test sites will receive conventional ultrasonic instrumentation followed by MINST performed with Mini-Five Gracey curettes under magnification loupes. All participants will receive oral hygiene instructions and full-mouth supragingival periodontal therapy before subgingival treatment. Scaling and root planing will be completed over two treatment sessions separated by one week. Professional supportive periodontal therapy will be provided during follow-up according to the study protocol. Clinical evaluations will be performed at baseline, 3 months, and 6 months. The primary clinical variables include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL). Microbiological evaluation using the benzoyl-DL-arginine naphthylamide (BANA) assay will also be performed at the same follow-up intervals. The objective of the study is to determine whether MINST provides improved clinical periodontal outcomes compared with conventional non-surgical periodontal therapy in molar teeth affected by Stage III/IV periodontitis.
Interventions
Minimally Invasive Non-Surgical Therapy (MINST) consists of subgingival scaling and root planing performed using Mini-Five Gracey curettes under ×4.0 magnification loupes following conventional ultrasonic instrumentation. The procedure is designed to minimize soft tissue trauma while improving access to deep periodontal pockets and root surface debridement. Treatment is completed in two sessions separated by one week.
Conventional non-surgical periodontal therapy consisting of subgingival scaling and root planing performed using ultrasonic instruments. Treatment is completed over two sessions separated by one week according to the study protocol.
Sponsors
Study design
Intervention model description
This is a randomized split-mouth clinical trial in which bilateral molar teeth within the same participant are randomly assigned to either the test or control intervention, allowing each participant to serve as their own control.
Eligibility
Inclusion criteria
* Adults aged 18 to 35 years. * Diagnosed with Stage III or Stage IV periodontitis. * Systemically healthy. * Presence of at least two bilateral molar teeth with probing pocket depth (PPD) ≥5 mm and bleeding on probing (BOP). * At least 20 remaining teeth. * Radiographic evidence of periodontal bone loss. * Non-smokers and non-users of tobacco or alcohol. * Not pregnant or breastfeeding. * Not receiving medications known to affect periodontal healing. * Willing and able to provide written informed consent and comply with study procedures.
Exclusion criteria
* Individuals who do not meet the inclusion criteria. * Pregnancy or breastfeeding. * Presence of systemic diseases or medical conditions affecting periodontal status or healing. * Current use of medications that may influence periodontal healing. * Current smokers or users of tobacco or alcohol. * Individuals unwilling or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth (PPD) | Baseline, 3 months, and 6 months | Change in probing pocket depth (PPD) measured in millimeters using a UNC-15 periodontal probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) | Baseline, 3 months, and 6 months | Change in clinical attachment level (CAL) measured in millimeters using a UNC-15 periodontal probe. |
| Bleeding on Probing (BOP) | Baseline, 3 months, and 6 months | Change in bleeding on probing (BOP). |
| Plaque Index (PI) | Baseline, 3 months, and 6 months | Change in Plaque Index (PI). |
| BANA Test | Baseline, 3 months, and 6 months | Changes in subgingival microbial profile assessed using the benzoyl-DL-arginine naphthylamide (BANA) assay. |
Countries
Turkey (Türkiye)