Imaging Analysis Following Periodontal Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis; Healing Wound
• Intervention / Treatment: Procedure: Simplified papilla preservation flap; Procedure: Resective periodontal flap with osseous recontouring

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AD
    • Queen Mary University London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simplified papilla preservation flap; 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.	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.; Other Names: SPPF
Active Comparator: Resective flap with osseous recontouring; 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.	Procedure: 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.; Other Names: RPFO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Study Director: Nikos Donos, Prof., Institute of Dentistry, QMUL; Principal Investigator: Nikos Donos, Prof., Institute of Dentistry, QMUL

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: postoperative healing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 17/LO/1428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No