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Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)

Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae 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
IRCT20221021056257N1
Enrollment
30
Registered
2022-11-09
Start date
2022-11-12
Completion date
Unknown
Last updated
2022-11-21

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: One of the surgical sites will be randomly selected as the intervention group and the tested substance will be used in this area. Intervention 2: Control group: the

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Having a favorable general health condition Being available during the 12 weeks of study Non- smoker patients Diagnosis of periodontitis, as defined by at least three non-contiguous interproximal pockets with pocket depth (PPDs) greater than 4mm or other radiographic evidence such as alveolar bone loss Patients who show PPD = 6mm after non-surgical treatment and periodontal surgery is indicated.

Exclusion criteria

Exclusion criteria: Pregnant women People who had used antibiotics and anti-inflammatory drugs within a month before surgery Patients who use orthodontic appliances Patients using the removable prosthesis Patients with intraoral pathological conditions Patients with 5 or more decayed teeth Patients who had participated in another study during the last 1 month Patients with a history of allergic reaction to health care products Patients who are forbidden to eat or drink liquids for 4 hours due to medical conditions

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: In order to check the amount of Swelling, the number 0 will be used for the absence of Swelling, the number 1 for moderate Swellingand 2 for significant Swelling. In order to evaluate the color of the gums, while comparing with the opposite side, the numbers 0 will be used for no redness, 1 for moderate redness and 2 for significant redness. To measure the depth of the probe pocket and CAL, the reference of these measurements will be from the Cementoenamel Junction. Bleeding index and Plaque index will be measured on 6 surfaces of the involved teeth and finally the measurements will be presented as an average. The presence or absence of bleeding during the probe will be recorded with two scales: 0 for no bleeding and 1 for bleeding. The presence or absence of plaque will also be measured with the same scale along the gingival margin. Also, to measure the variables of the questionnaire, in order to check the level of pain, the Visual Analogue Scale, which is a visual analog index with a degree of pain from 0 to 10, will be used. The amount of swelling of the mucous membrane and face will be asked with two options: no swelling and high swelling, and the presence or absence of bleeding in the area after surgery will be asked. The patient is requested not to refer to the information of the previous days when completing the questionnaire daily.

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