Intrabony Periodontal DefectsNCT07822659
Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects
A study testing minimally invasive non-surgical therapy and minimally invasive periodontal surgery in people with Intrabony Periodontal Defects, run by Cairo University.
Trial summary
This study aims to evaluate the clinical and 3D radiographic effects of minimally invasive non-surgical periodontal therapy (MINST) compared to single flap approach (SFA) in management of intrabony defects in stage III or IV periodontitis patients. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Intrabony Periodontal Defects
- What is being tested?
- minimally invasive non-surgical therapy and minimally invasive periodontal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 28 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
This study aims to evaluate the clinical and 3D radiographic effects of minimally invasive non-surgical periodontal therapy (MINST) compared to single flap approach (SFA) in management of intrabony defects in stage III or IV periodontitis patients.
Read the 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.
- Conditions
- Intrabony Periodontal Defects
- Being tested
- minimally invasive non-surgical therapy, minimally invasive periodontal surgery
- Keywords
- stage III periodontitis patients, stage IV periodontitis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive non-surgical therapyProcedure or surgery
non-surgical periodontal therapy using minimally invasive approach
minimally invasive periodontal surgeryProcedure or surgery
Single flap approach
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Arm 1 Receives: Procedure: minimally invasive non-surgical therapy |
| Control | Active comparator | arm 2 Receives: Procedure: minimally invasive periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (10)
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).
Measured: Baseline and 6 months
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.
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
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).
Measured: Baseline
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).
Measured: 1 week and 8 weeks postoperative
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.
Measured: 1 week postoperative
Cost effectiveness
Cost effectiveness analysis via calculation of ICER (Incremental Cost-Effectiveness Ratio) will be done 6 months postoperatively
Measured: 6 months
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).
Measured: 1-week postoperative
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).
Measured: 6-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israa Bakri, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822659
- Sponsor's protocol ID
- Esraa2026
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36661562Trombelli 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.
PubMed 20528696Nibali 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.
PubMed 26257238
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07822659
- Acronym / sponsor ID
- Esraa2026
- Conditions
- Intrabony Periodontal Defects
- Keywords
- stage III periodontitis patients, stage IV periodontitis patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the clinical and 3D radiographic effects of minimally invasive non-surgical periodontal therapy (MINST) compared to single flap approach (SFA) in management of intrabony defects in stage III or IV periodontitis patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: minimally invasive non-surgical therapyArm 1 |
| Control | Active comparator | Procedure: minimally invasive periodontal surgeryarm 2 |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive non-surgical therapynon-surgical periodontal therapy using minimally invasive approach | Procedure or surgery | Intervention |
| minimally invasive periodontal surgerySingle flap approach | Procedure or surgery | Control |
Primary outcome
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.
10 secondary outcomes
Radiographic defect depth reduction (RDR)
Time frame: Baseline and 6 months
Plaque index
Time frame: Baseline, 3 months and 6 months
Bleeding on Probing
Time frame: Baseline, 3 months and 6 months
Pocket depth (PD) reduction
Time frame: Baseline, 3 months and 6 months
Chair time
Time frame: Baseline
Healing
Time frame: 1 week and 8 weeks postoperative
Oral health-related quality of life
Time frame: 1 week postoperative
Cost effectiveness
Time frame: 6 months
Visual Analog Scale (VAS) pain score
Time frame: 1-week postoperative
Post-operative patient satisfaction
Time frame: 6-month postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 36661562Anoixiadou 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.
- Background: PubMed 20528696Trombelli 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.
- Background: PubMed 26257238Nibali 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive non-surgical therapy and minimally invasive periodontal surgery in people with Intrabony Periodontal Defects, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact esraa Israa Bakri, Periodontist (00201152027693, esraabakri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAL gain (time frame: Baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07822659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.