Healing Wound, Periodontitis
Conditions
Keywords
postoperative healing
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.
Interventions
PROCEDURESimplified 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.
PROCEDUREResective 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.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The calibrated examiners will be blinded to the study treatment. Samples will be labelled anonymously with subject ID and without codes relating to treatment group; therefore, all sample analyses will be blinded. Blinding of the statistician will also take place. Data will be coded during data entry according to treatment group with a number disallowing group identification during analyses. Code details of which each treatment group will be revealed only once analyses are complete.
Intervention model description
Single centre, randomised, single-blind, parallel-group clinical trial.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometrical (3D) imaging in post-periodontal surgery wound healing. | 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). |
| Thermal (2D) imaging in post-periodontal surgery wound healing. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcome measures (PROMs) particularly on oral health related quality of life | 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. |
Countries
United Kingdom
Contacts
STUDY_DIRECTORNikos Donos, Prof.
Institute of Dentistry, QMUL
PRINCIPAL_INVESTIGATORNikos Donos, Prof.
Institute of Dentistry, QMUL
Outcome results
None listed