An interventional study of Minimally invasive non-surgical therapy (MINST) and 0.8% High-Molecular-Weight Hyaluronic Acid Gel in Periodontitis, sponsored by Amina Fouad Farag. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Amina Fouad Farag · Not applicable, Interventional, and Treatment
Among 119 studies in Periodontitis with a site in Egypt — 28 open to participants now, 37 under way, 3 of them phase 3. Periodontitis · Egypt.
Among the 119 studies in Periodontitis with a site in Egypt, this one is the 9th largest by enrollment of the 101 interventional ones that give a count, is one of 20 that started in 2023, is one of 61 with no phase, and was the 119th registered.
1,232 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
Browse Periodontitis studies →28 of the 119 studies in Periodontitis with a site in Egypt are open now. Recruiting first, the newest first:
October 6 University · Sites in Egypt
Ages 25–45
Doaa Atta Aid · Sites in Egypt
gehad samy · Sites in Egypt
Ages 30–60
Cairo University · Sites in Egypt
Ages 18+
Mansoura University · Sites in Egypt
Ages 20–40 · Healthy volunteers
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.
This study: 20 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
119 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 16 · Phase 3 7 · Phase 4 5
First in 2014; this study’s year is marked. 20 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 66 is above the median of 44 across 847 interventional studies indexed under Periodontitis.
Median enrollment 30 across the 101 interventional studies, 71 across the 18 observational. Of the 70 that completed or were terminated, 0 (0%) have results posted.
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None of the 119 has an industry lead sponsor. The 10 most frequent:
Amina Fouad Farag is the lead sponsor of 4 studies on the registry; none are open to participants now.
Amina Fouad Farag has 1 study filed under Periodontitis — fewer than ten, so there is no comparison to draw.
8 of the studies in Periodontitis with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07368699Alexandria UniversityActive Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis | 2026-12 |
| NCT07731113Cairo UniversityEvaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis | 2026-12-10 |
| NCT07725393gehad samyAdjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis | 2027-01 |
| NCT07599657Cairo UniversitySurfactant Protein D Levels in GCF Before and After MINST in Periodontitis | 2027-02-01 |
| NCT07928752Badr UniversityEffects of Adjunctive Melatonin Gel in Type II Diabetics With Stage III-IV Periodontitis | 2027-03 |
Add all 8 to your calendar (.ics) → With an account.
Among the 119 studies in Periodontitis with a site in Egypt, from their registry updates:
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Background: Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues, resulting from an imbalance between the host immune response and periodontopathogenic bacteria. Minimally invasive non-surgical therapy (MINST) reduces soft-tissue trauma and preserves clot stability. Healing may be further enhanced by two adjuncts: high-molecular-weight hyaluronic acid (HA), which has anti-inflammatory and mucoadhesive properties, and concentrated growth factor (CGF), an autologous platelet concentrate. Vascular endothelial growth factor (VEGF) in gingival crevicular fluid (GCF) serves as a marker of inflammation, angiogenesis and healing.
Aim: This study evaluated the clinical and biochemical outcomes of 0.8% HA gel and liquid CGF as adjuncts to MINST in stage II-III periodontitis. The primary outcome was clinical attachment level (CAL) gain at 6 months. Secondary outcomes were probing depth (PD), bleeding on probing (BoP), gingival index (GI), plaque index (PI) and GCF VEGF levels at 1, 3 and 6 months.
Subjects and Methods: This three-arm, parallel-group randomized clinical trial included 66 systemically healthy non-smokers aged 20-40 years with stage II-III periodontitis and pockets of at least 5 mm. Patients were recruited at the Faculty of Dentistry, October 6 University, under ethics approval RECO6U/34-2023. A sample size of 22 per group was calculated with G*Power (α = 0.05, power 80%, effect size 0.4). After an initial hygiene phase, patients whose full-mouth plaque and bleeding scores fell below 20% were randomized by computer-generated sequence into three groups. Group I received MINST alone. Group II received MINST plus 0.8% HA gel injected subgingivally and repeated after 4 weeks. Group III received MINST plus liquid CGF, prepared from about 9 mL of the patient's venous blood, injected subgingivally and repeated after 4 weeks. MINST was performed under local anesthesia with 5× loupes and Gracey Mini Five curettes, without irrigation. The deepest interproximal site in each patient served as the experimental site. A single calibrated, blinded examiner recorded the clinical parameters at baseline, 1, 3 and 6 months. GCF was collected with paper points, and VEGF was measured by ELISA. CAL, PD and VEGF were analyzed by mixed MANOVA with Bonferroni correction. PI and GI were analyzed with the Kruskal-Wallis, Mann-Whitney, Friedman and Wilcoxon tests, and BoP with the chi-square, Cochran's Q and McNemar tests.
Results: All 66 patients completed follow-up. The groups were comparable at baseline (p > 0.05), and all improved significantly over time (p \< 0.001).
Mean baseline CAL was similar in Groups I, II and III (5.36, 5.41 and 5.32 mm). At 6 months it had fallen to 3.86, 3.36 and 3.05 mm, giving mean gains of 1.50, 2.05 and 2.27 mm respectively. Both adjunct groups gained more attachment than the control from the first month onward, and CGF gained more than HA at 3 and 6 months (p = 0.03).
Mean PD fell from 5.50, 5.36 and 5.41 mm at baseline to 3.82, 3.41 and 2.95 mm at 6 months, reductions of 1.68, 1.95 and 2.46 mm. CGF gave a greater PD reduction than HA at 3 months (p = 0.01) and 6 months (p = 0.002).
GCF VEGF started at similar levels in all groups (about 1790-1820 pg/mL) and fell significantly at every interval. At 6 months it was 1341.40 pg/mL in Group I, 1264.82 pg/mL in Group II and 1182.66 pg/mL in Group III. The CGF group had the lowest levels at 3 and 6 months compared with HA (p = 0.01) and control (p = 0.001).
PI and GI improved in all groups; PI was significantly better with CGF at 3 and 6 months, and GI with CGF at 3 months (p = 0.001), with no GI difference between groups at 6 months.
BoP was present in 20 of 22 patients (90.9%) in each group at baseline. At 1 month it was present in 54.5%, 31.8% and 13.6% of patients in Groups I, II and III (p = 0.016), and in no patient at 3 and 6 months.
Limitations: The study was carried out at a single centre, with a 6-month follow-up and one experimental site per patient. No radiographic or histological assessment was performed, so CAL gain reflects clinical repair through a long junctional epithelium rather than proven regeneration. The control group received no placebo, so the greater PI improvement in the adjunct groups may reflect performance bias. VEGF was first resampled at 1 month, after the early growth-factor release from CGF. Only healthy non-smokers aged 20-40 years were included.
Conclusion: Adding HA gel or liquid CGF to MINST produced greater clinical and biochemical improvement than MINST alone over 6 months in stage II-III periodontitis. CGF was the most effective adjunct for CAL gain, PD reduction and lowering GCF VEGF.
Introduction Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues that leads to destruction of the connective tissue attachment and alveolar bone. It results from an imbalance between the host immune response and periodontopathogenic bacteria. The 2017 AAP/EFP World Workshop introduced a new classification of periodontal and peri-implant diseases, published in 2018.
Diagnosis still relies mainly on clinical and radiographic examination, which cannot detect early disease activity or predict prognosis. Biomarkers in gingival crevicular fluid (GCF), such as vascular endothelial growth factor (VEGF), are therefore of growing interest as objective indicators of inflammation, angiogenesis and healing.
Non-surgical periodontal therapy is the cornerstone of treatment. Minimally invasive non-surgical therapy (MINST) refines this approach by minimizing soft-tissue trauma and preserving clot stability. Adjunctive agents may further enhance healing: high-molecular-weight hyaluronic acid (HA) has anti-inflammatory, mucoadhesive and wound-healing properties, while concentrated growth factor (CGF) is an autologous platelet concentrate rich in growth factors.
Aim of the Study The aim of this study was to evaluate the clinical and biochemical outcomes of high-molecular-weight HA gel and liquid CGF as adjuncts to MINST in the treatment of stage II and III periodontitis. The primary outcome was clinical attachment level (CAL) gain at 6 months. Secondary outcomes were changes in probing depth (PD), bleeding on probing (BoP), gingival index (GI), plaque index (PI) and GCF VEGF levels at 1, 3 and 6 months.
Subjects and Methods This prospective, three-arm, parallel-group randomized clinical trial included 66 systemically healthy, non-smoking patients aged 20-40 years with stage II-III periodontitis and pockets ≥ 5 mm. Patients were recruited from the Periodontology Clinic, Faculty of Dentistry, October 6 University, and the study was approved by the Research Ethics Committee (RECO6U/34-2023). The sample size (22 per group) was calculated with G*Power (α = 0.05, power = 80%, effect size = 0.4).
After an initial hygiene phase, only patients achieving FMPS and FMBS below 20% were randomized by computer-generated sequence into three groups:
MINST was performed under local anesthesia with 5x loupes and Gracey Mini Five curettes, without subgingival irrigation. The deepest interproximal site in each patient served as the experimental site. A single calibrated, blinded examiner recorded CAL, PD, BoP, GI and PI with a UNC-15 probe at baseline, 1, 3 and 6 months. GCF was collected with #40 paper points at the same intervals, and VEGF was measured by ELISA.
Data were analyzed with SPSS v25 using mixed MANOVA with Bonferroni correction (CAL, PD, VEGF), Kruskal-Wallis, Mann-Whitney, Friedman and Wilcoxon tests (PI, GI), and chi-square, Cochran's Q and McNemar tests (BoP). Significance was set at p \< 0.05.
Results All 66 patients completed the 6-month follow-up. The groups did not differ significantly at baseline in any parameter (p > 0.05), and all groups improved significantly over time (p \< 0.001). At 3 and 6 months, Group III (CGF) showed the best outcomes, followed by Group II (HA), then the control group.
Parameter (mean ± SD) Time Group I (MINST) Group II (MINST + HA) Group III (MINST + CGF) CAL (mm) Baseline 5.36 ± 0.49 5.41 ± 0.50 5.32 ± 0.48 CAL (mm) 6 months 3.86 ± 0.47 3.36 ± 0.49 3.05 ± 0.21 PD (mm) Baseline 5.50 ± 0.51 5.36 ± 0.49 5.41 ± 0.50 PD (mm) 6 months 3.82 ± 0.40 3.41 ± 0.50 2.95 ± 0.38 VEGF (pg/mL) Baseline 1795.40 ± 84.40 1818.53 ± 80.61 1788.96 ± 64.21 VEGF (pg/mL) 6 months 1341.40 ± 100.02 1264.82 ± 92.76 1182.66 ± 82.73
Conclusion and Recommendations Adjunctive use of HA gel or liquid CGF with MINST produced greater clinical and biochemical improvement than MINST alone over 6 months in stage II-III periodontitis. CGF was the most effective adjunct for CAL gain, PD reduction and lowering GCF VEGF levels.
Recommendations:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subgingival debridement under local anesthesia with 5× loupes and Gracey Mini Five curettes, using a subpapillary approach, without irrigation.
Procedure: Minimally invasive non-surgical therapy (MINST)
MINST followed by subgingival injection of 0.8% HA gel until overflow, repeated after 4 weeks.
Procedure: Minimally invasive non-surgical therapy (MINST) · Device: 0.8% High-Molecular-Weight Hyaluronic Acid Gel
MINST followed by subgingival injection of CGF prepared from about 9 mL of venous blood (Medifuge, Silfradent), repeated after 4 weeks.
Procedure: Minimally invasive non-surgical therapy (MINST) · Biological: Concentrated Growth Factor (CGF), autologous
Description: Subgingival debridement following the MINST protocol (Nibali et al.), done under local anesthesia with 5× magnification loupes and Gracey Mini Five curettes (Hu-Friedy). A subpapillary approach preserves the papillae. Roots are cleaned to the base of the pocket without excessive root planing or gingival curettage, and the pocket is not irrigated, to keep the blood clot stable. All pockets deeper than 3 mm are treated in a single session, after a 4-week initial hygiene phase.
Also known as: MINST; minimally invasive subgingival instrumentation
Immediately after MINST, 0.8% high-molecular-weight hyaluronic acid gel is injected into the pocket at the experimental site with a sterile syringe and blunt plastic needle until it overflows the gingival margin. The application is repeated 4 weeks later. Patients avoid eating and drinking for 1 hour and brushing the treated site for 24 hours.
Also known as: HA gel
About 9 mL of the patient's venous blood is collected into sterile plastic tubes without anticoagulant or clot activator. The tubes are centrifuged in a Medifuge (Silfradent) with the alternating-speed CGF program (2700, 2400, 2700 and 3000 rpm; 692-855 × g). The upper liquid fraction is aspirated and, immediately after MINST and before it clots, injected into the pocket at the experimental site with a blunt needle until it overflows the gingival margin. The application is repeated 4 weeks later. No periodontal dressing is used.
Also known as: CGF, autologous platelet concentrate
Change in Clinical Attachment Level (CAL)
Distance in millimetres from the cemento-enamel junction to the base of the pocket, measured at the experimental site (the deepest interproximal pocket) with a UNC-15 probe by a calibrated examiner. CAL gain = baseline CAL minus CAL at each follow-up. The 6-month CAL gain is the main end-point; the 1- and 3-month values describe the course of attachment gain.
Time frame: Baseline, 1 month, 3 months and 6 months after treatment
Change in Probing Depth (PD)
Distance in millimetres from the gingival margin to the base of the pocket at the experimental site, measured with a UNC-15 probe.
Time frame: Baseline, 1, 3 and 6 months
Bleeding on Probing (BoP)
Presence or absence of bleeding within 30 seconds after gentle probing of the experimental site, reported as the number and percentage of patients with BoP.
Time frame: Baseline, 1, 3 and 6 months
Gingival Index (GI)
Löe \& Silness index scored 0-3 (0 = normal gingiva; 3 = severe inflammation with spontaneous bleeding) at the experimental tooth.
Time frame: Baseline, 1, 3 and 6 months
Plaque Index (PI)
Silness \& Löe index scored 0-3 (0 = no plaque; 3 = abundant soft deposits) at the experimental tooth.
Time frame: Baseline, 1, 3 and 6 months
Gingival Crevicular Fluid VEGF Level
Vascular endothelial growth factor in GCF collected with a sterile #40 paper point placed for 30 seconds at the experimental site, measured by human VEGF sandwich ELISA (pg/mL).
Time frame: Baseline, 1, 3 and 6 months
Plan to share: No — Individual participant data will not be shared publicly, in accordance with the data protection policy of the Research Ethics Committee, Faculty of Dentistry, October 6 University. Aggregate results are available in the published article. De-identified data may be made available by the corresponding author on reasonable request, subject to approval by the Research Ethics Committee.
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Nov 2024, 12 months.
Of 481 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 12 months is below that.
Counting every sponsor, half of 495 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Amina Fouad Farag