Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects
Clinical and 3D Radiographic Evaluation of Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects: A Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Minimally invasive non-surgical therapy (MINST) offers a tissue-preserving, patient-friendly approach that reduces morbidity, chair-time, and postoperative complications. However, existing studies on MINST are limited in scale, often lack long-term follow-up, and vary in clinical protocols, leading to inconsistent evidence on its predictability and efficacy compared to surgical modalities (Nibali et al., 2015; Barbato et al., 2024). Moreover, the biological mechanisms underlying MINST, particularly its ability to facilitate stable blood clot formation and support periodontal regeneration, are not yet fully clarified (Mehta et al., 2024). Given the growing emphasis on cost-effective, patient-centered care and the increasing population of individuals with medical or psychological contraindications to surgery, a deeper investigation into MINST as a stand-alone treatment is both timely and critical.
While MINST has emerged as a promising approach for managing periodontal intrabony defects, a critical limitation of current evidence lies in the lack of detailed characterization of defect morphology. Due to the non-surgical nature of the approach, the precise configuration of the defects; including their depth, width, angulation, and number of remaining bony walls, often remains undetermined, which restricts the ability to correlate defect characteristics with clinical outcomes. This is significant because it is well-established that defect morphology plays a crucial role in the success of regenerative periodontal treatments (Kasaj et al., 2008). Without detailed radiographic assessment, particularly using preoperative three-dimensional imaging modalities such as CBCT, it is challenging to ascertain which defect types are most suitable for MINST versus those that may benefit more from surgical intervention (Anoixiadou et al., 2023).
Consequently, there is a clear need for studies integrating preoperative 3D evaluation to better define the indications, advantages, and limitations of MINST in relation to defect-specific anatomical variables. Nonetheless, as periodontal therapy shifts toward less invasive, patient-centered care models, evaluating the efficacy of MINST with robust morphological diagnostics becomes an essential step in optimizing treatment outcomes and guiding evidence-based clinical decision-making.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: esraa Israa Bakri, Periodontist
- Telefoonnummer: 00201152027693
- E-mail: esraabakri@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Stage III or IV periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with pocket depth (PD) ≥ 6 mm.
- Able to sign an informed consent form.
- Patients who are cooperative, motivated, and hygiene conscious.
- Systemically free according to Cornell Medical Index (Broadbent, 1951).
Exclusion Criteria:
- Pregnancy or breast feeding
- Smoking (current or in the past 5 years).
- The presence of an orthodontic appliance
- Periodontal therapy carried out in the past 6 months
- History of intake of antibiotics or other medications affecting the periodontium in the previous 3 months.
- Handicapped and patients with psychological conditions.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention
Arm 1
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non-surgical periodontal therapy using minimally invasive approach
|
|
Actieve vergelijker: Control
arm 2
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Single flap approach
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
CAL gain
Tijdsspanne: Baseline, 3 months and 6 months
|
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. |
Baseline, 3 months and 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Radiographic defect depth reduction (RDR)
Tijdsspanne: Baseline and 6 months
|
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).
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Baseline and 6 months
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Plaque index
Tijdsspanne: Baseline, 3 months and 6 months
|
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. |
Baseline, 3 months and 6 months
|
|
Bleeding on Probing
Tijdsspanne: Baseline, 3 months and 6 months
|
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. |
Baseline, 3 months and 6 months
|
|
Pocket depth (PD) reduction
Tijdsspanne: Baseline, 3 months and 6 months
|
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. |
Baseline, 3 months and 6 months
|
|
Chair time
Tijdsspanne: Baseline
|
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).
|
Baseline
|
|
Healing
Tijdsspanne: 1 week and 8 weeks postoperative
|
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). |
1 week and 8 weeks postoperative
|
|
Oral health-related quality of life
Tijdsspanne: 1 week postoperative
|
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. |
1 week postoperative
|
|
Cost effectiveness
Tijdsspanne: 6 months
|
Cost effectiveness analysis via calculation of ICER (Incremental Cost-Effectiveness Ratio) will be done 6 months postoperatively
|
6 months
|
|
Visual Analog Scale (VAS) pain score
Tijdsspanne: 1-week postoperative
|
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).
|
1-week postoperative
|
|
Post-operative patient satisfaction
Tijdsspanne: 6-month postoperative
|
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).
|
6-month postoperative
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
- Trombelli L, Simonelli A, Pramstraller M, Wikesjo UM, Farina R. Single flap approach with and without guided tissue regeneration and a hydroxyapatite biomaterial in the management of intraosseous periodontal defects. J Periodontol. 2010 Sep;81(9):1256-63. doi: 10.1902/jop.2010.100113.
- Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.
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Andere studie-ID-nummers
- Esraa2026
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