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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03631693
Other study ID # 17/LO/1428
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 21, 2018
Est. completion date June 30, 2024

Study information

Verified date December 2023
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Simplified papilla preservation flap
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.
Resective periodontal flap with osseous recontouring
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.

Locations

Country Name City State
United Kingdom Queen Mary University London London

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometrical (3D) imaging in post-periodontal surgery wound healing. 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). Period from pre-surgery to 90 days post-surgery
Primary Thermal (2D) imaging in post-periodontal surgery wound healing. Subtracted thermography images from the baseline will identify the change of the tissue temperature in the area of surgery (extra and intra orally). Period from pre-surgery to 90 days post-surgery
Secondary Patient related outcome measures (PROMs) particularly on oral health related quality of life 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. Period from pre-surgery to 90 days post-surgery
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