CompletedNot Applicable

Imaging Analysis Following Periodontal Surgery

United Kingdom60 participantsStarted 2018-02-21

Plain-language summary

This is a single centre, randomised, single-blind, parallel-group clinical trial that aims at evaluating the use of imaging (2D and 3D) in obtaining geometric and thermometric changes of postoperative healing patterns and comorbidities (facial swelling, oedema and inflammation) following two routine surgical procedures performed for the treatment of periodontal (gum) disease.

Who can participate

Age range30 Years

SexALL

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Inclusion criteria

✓. Systemically healthy males and females ≥ 30 years of age.
✓. Participants must be willing to read, and sign a copy of the "Informed Consent Form" (ICF) form after reading the, "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained.
✓. Participants must present with clinical and radiographic evidence of periodontitis, with one interdental area of Periodontal Pocket Depth (PPD) ≥6mm, Bleeding On Probing (BOP), and Clinical Attachment Level (CAL) ≥6mm in any posterior sextant of their mouth (excluding third molars and the distal aspect of the second molars), or multiple sites (≥9) with PPD ≥5mm, BOP, and CAL ≥5mm.
✓. Participants must have completed a course of non-surgical periodontal therapy within 2 years prior to study commencement and have had maintenance including subgingival debridement within 6 months prior to assessment for eligibility.

Exclusion criteria

✕. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. cardiovascular disease or AIDS.
✕. Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
✕. History of alcohol or drug abuse.
✕. Self-reported pregnancy or lactation.
✕. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of the data.

What they're measuring

Geometrical (3D) imaging in post-periodontal surgery wound healing.

Timeframe: Period from pre-surgery to 90 days post-surgery

Thermal (2D) imaging in post-periodontal surgery wound healing.

Timeframe: Period from pre-surgery to 90 days post-surgery

Trial details

NCT IDNCT03631693

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Healing Wound trials