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Completed

NCT Number: NCT03631693

Imaging Analysis Following Periodontal Surgery

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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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary University London

London, E1 2AD, United Kingdom

About this study

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

  • Simplified Papilla Preservation Flap (SPPF) which is a conservative flap aiming at preserving the tissues between teeth.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy males and females ≥ 30 years of age.
  • 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.
  • 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.
  • 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

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

Treatment and study plan

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.

Other names: SPPF

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.

Other names: RPFO

Primary outcomes

  1. Geometrical (3D) imaging in post-periodontal surgery wound healing.

    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).

  2. Thermal (2D) imaging in post-periodontal surgery wound healing.

    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).

Secondary outcomes

  1. Patient related outcome measures (PROMs) particularly on oral health related quality of life

    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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2018
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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