Queen Mary University London
London, E1 2AD, United Kingdom
NCT Number: NCT03631693
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.
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Notify Me30 year and older
All sexes
Interventional
Not applicable
London, E1 2AD, United Kingdom
A surgery in a posterior sextant will be performed per patient. The surgical procedures being compared for their post-operative healing patterns are:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The simplified papilla preservation flap (SPPF) surgery is a conservative surgical procedure aimed at the preservation of the tissues between the teeth providing access for the debridement of the root surface in sites with residual pockets.
Other names: SPPF
The Resective periodontal flap with osseous recontouring (RPFO) is a surgical procedure that achieves predictable pocket depth reduction by soft and hard tissue resection to obtain a more convenient soft and hard tissue architecture for oral hygiene.
Other names: RPFO
Time frame: Period from pre-surgery to 90 days post-surgery
Subtracted images from the baseline will identify the area and magnitude of the swelling (changes in volume) in the area of surgery (extra and intra orally).
Time frame: Period from pre-surgery to 90 days post-surgery
Subtracted thermography images from the baseline will identify the change of the tissue temperature in the area of surgery (extra and intra orally).
Time frame: Period from pre-surgery to 90 days post-surgery
The secondary objective of this study is to evaluate the impact of the two surgical procedures on patient related outcome measures (PROMs). The Oral impact on daily performances index (OIDP) is going to be used to evaluate health and treatment outcomes.
Queen Mary University of London
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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