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Clinical evaluation of the efficacy of nano-emul gel of Atorvastatin on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)

Clinical evaluation of the efficacy of nano-emul gel of Atorvastatin on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241227064183N1
Enrollment
50
Registered
2025-02-06
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounded tissue caused by periodontal flap surgery. Disruption of wound, not elsewhere classified

Interventions

Intervention 1: Intervention group: The surgical area in the patients mouth is randomly selected as the intervention group and the study material will used in this area. Intervention 2: Control group:

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients will be included in the study if they are: aged 18-75 years, in good general health, non-smokers, available during the 12-week study, have periodontitis, as defined by at least two non-adjacent interproximal sites with pocket depths (PPDs) greater than 4 mm or other radiographic evidence such as visible alveolar bone loss, and require periodontal surgery.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Pregnant women, lactating women, patients who have used antibiotics and anti-inflammatory drugs within 1 month before surgery, patients whose systemic disease has directly affected their periodontal disease (such as chronic use of steroids, bisphosphonates, calcitonin, methotrexate, and estrogens in the past 6 months), patients with removable restorations, patients using removable orthodontic appliances, periodontal treatment in the past year, patients who have participated in another study within the past 1 month, patients who have had allergic reactions to hygiene products, patients who are prohibited from eating or drinking fluids for 4 hours due to medical conditions, patients with 5 or more decayed teeth.

Design outcomes

Primary

MeasureTime frame
Clinical variables evaluated after surgery include soft tissue swelling, gum color, pocket probe depth, clinical attachment loss, bleeding index, plaque index. Also, during the first 7 days after surgery, patients will complete a questionnaire to evaluate post-surgery complaints, which includes the amount of pain experienced, the type of pain, the number of painkillers taken, swelling of the mucous membrane and swelling of the face, and swelling and bleeding of the gum. Timepoint: Examining the results of wound healing 1, 4 and 8 weeks following the surgery. Method of measurement: To assess the degree of swelling, the number 0 will be used for no swelling, the number 1 for moderate swelling, and the number 2 for significant swelling. To assess the color of gingiva, in comparison with the opposite side, the numbers 0 for no redness, 1 for moderate redness, and 2 for significant redness will be used. For measuring the depth of the pocket probe and CAL, the reference of these measurements will be from the CEJ. Bleeding index will be measured at 6 levels of the involved teeth and finally a numerical measure will be presented as an average. The presence or absence of bleeding during probing will be recorded with two scales: 0 for no bleeding and 1 for bleeding that is seen between 0 and 30 seconds after probing. The presence or absence of plaque will also be measured with the same scale along the gingival margin.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Kouhsoltani

Tabriz University of Medical Sciences

mkoohsoltani@yahoo.com+98 41 3335 5965

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026