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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: esraa Israa Bakri, Periodontist
- Phone Number: 00201152027693
- Email: esraabakri@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Arm 1
|
non-surgical periodontal therapy using minimally invasive approach
|
|
Active Comparator: Control
arm 2
|
Single flap approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CAL gain
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic defect depth reduction (RDR)
Time Frame: 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).
|
Baseline and 6 months
|
|
Plaque index
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Esraa2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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