Clinical trial NCT03631693: Imaging Analysis Following Periodontal Surgery
Official title: The Use of Non-invasive Thermal and Geometrical Surface Imaging on Postoperative Healing Patterns Following Routine Surgical Procedures Used for the Treatment of Periodontal Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healing Wound
Periodontitis
Keywords: postoperative healing
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, randomised, single-blind, parallel-group clinical trial.
Primary purpose: OTHER

Brief 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.

Detailed description: A surgery in a posterior sextant will be performed per patient. The surgical procedures being compared for their post-operative healing patterns are:

1. Simplified Papilla Preservation Flap (SPPF) which is a conservative flap aiming at preserving the tissues between teeth.
2. Resective Periodontal Flap with Osseous Recontouring (RPFO) which is a conventional surgery which involves hard and soft tissues resection.

Geometric (3D) surface imaging and thermal (2D) surface imaging will be used to assess the post-operative healing patterns and comorbidities (facial swelling, oedema and inflammation) following either of the surgical procedures.

Eligibility criteria: Inclusion Criteria:

1. Systemically healthy males and females ≥ 30 years of age.
2. 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.
3. 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.
4. 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:

1. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. cardiovascular disease or AIDS.
2. Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
3. History of alcohol or drug abuse.
4. Self-reported pregnancy or lactation.
5. 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.

Primary outcomes:
measure: Geometrical (3D) imaging in post-periodontal surgery wound healing.
timeFrame: Period from pre-surgery to 90 days post-surgery
measure: Thermal (2D) imaging in post-periodontal surgery wound healing.
timeFrame: Period from pre-surgery to 90 days post-surgery
Secondary outcomes:
measure: Patient related outcome measures (PROMs) particularly on oral health related quality of life
timeFrame: Period from pre-surgery to 90 days post-surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University London
Study officials:
affiliation: Institute of Dentistry, QMUL
name: Nikos Donos, Prof.
role: STUDY_DIRECTOR
affiliation: Institute of Dentistry, QMUL
name: Nikos Donos, Prof.
role: PRINCIPAL_INVESTIGATOR
References: