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Imaging Analysis Following Periodontal Surgery

Primary Purpose

Healing Wound, Periodontitis

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Simplified papilla preservation flap
Resective periodontal flap with osseous recontouring
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healing Wound focused on measuring postoperative healing

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Mary University London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Simplified papilla preservation flap

Resective flap with osseous recontouring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2018
Last Updated
May 30, 2023
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT03631693
Brief Title
Imaging Analysis Following Periodontal Surgery
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing Wound, Periodontitis
Keywords
postoperative healing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single centre, randomised, single-blind, parallel-group clinical trial.
Masking
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simplified papilla preservation flap
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Resective flap with osseous recontouring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Simplified papilla preservation flap
Other Intervention Name(s)
SPPF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Resective periodontal flap with osseous recontouring
Other Intervention Name(s)
RPFO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Geometrical (3D) imaging in post-periodontal surgery wound healing.
Description
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).
Time Frame
Period from pre-surgery to 90 days post-surgery
Title
Thermal (2D) imaging in post-periodontal surgery wound healing.
Description
Subtracted thermography images from the baseline will identify the change of the tissue temperature in the area of surgery (extra and intra orally).
Time Frame
Period from pre-surgery to 90 days post-surgery
Secondary Outcome Measure Information:
Title
Patient related outcome measures (PROMs) particularly on oral health related quality of life
Description
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.
Time Frame
Period from pre-surgery to 90 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikos Donos, Prof.
Organizational Affiliation
Institute of Dentistry, QMUL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nikos Donos, Prof.
Organizational Affiliation
Institute of Dentistry, QMUL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary University London
City
London
ZIP/Postal Code
E1 2AD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Imaging Analysis Following Periodontal Surgery

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