Imaging Analysis Following Periodontal Surgery

NCT03631693 | Completed

• 1 other identifier: 17/LO/1428
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Wound; Periodontitis

Keywords

postoperative healing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Period from pre-surgery to 90 days post-surgery

Study Arms (2)

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.

Procedure: Simplified papilla preservation flap

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.

Procedure: Resective periodontal flap with osseous recontouring

Interventions

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.

Also known as: SPPF

Simplified papilla preservation flap

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.

Also known as: RPFO

Resective flap with osseous recontouring

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University London

London, E1 2AD, United Kingdom

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nikos Donos, Prof.

  Institute of Dentistry, QMUL

  STUDY DIRECTOR

• Nikos Donos, Prof.

  Institute of Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, randomised, single-blind, parallel-group clinical trial.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: August 15, 2018
• Study Start: February 21, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)