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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplified papilla preservation flap | Active Comparator | PERIODONTAL SURGICAL INTERVENTION:The first arm is the simplified papilla preservation flap (SPPF) surgery.At visit 3, the SPPF surgery is performed. 2D and 3D imaging on surgical site will be carried out pre and post surgery. 2D and 3D imaging performed on surgical site for all post operative visits. |
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| Resective flap with osseous recontouring | Active Comparator | PERIODONTAL SURGICAL INTERVENTION: The second arm is the Resective periodontal flap with osseous recontouring (RPFO). At visit 3, the RPFO surgery is performed. 2D and 3D imaging on surgical site will be carried out pre and post surgery. 2D and 3D imaging performed on surgical site for all post operative visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified papilla preservation flap | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikos Donos, Prof. | Institute of Dentistry, QMUL | Study Director |
| Nikos Donos, Prof. | Institute of Dentistry, QMUL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary University London | London | E1 2AD | United Kingdom |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Single centre, randomised, single-blind, parallel-group clinical trial.
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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.
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| Resective periodontal flap with osseous recontouring | Procedure | 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. |
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