Imaging Analysis Following Periodontal Surgery

NCT ID: NCT03631693

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2025-12-31

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:

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.

Conditions

Healing Wound; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Simplified papilla preservation flap

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Resective periodontal flap with osseous recontouring

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SPPF; RPFO

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikos Donos, Prof.

Role: STUDY_DIRECTOR

Institute of Dentistry, QMUL

Nikos Donos, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute of Dentistry, QMUL

Locations

Queen Mary University London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

17/LO/1428

Identifier Type: -

Identifier Source: org_study_id