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CompletedNCT03631693Updated Feb 19, 2026

Imaging Analysis Following Periodontal Surgery

An interventional study of Simplified papilla preservation flap and Resective periodontal flap with osseous recontouring in Healing Wound and Periodontitis, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Queen Mary University of London · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2018, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Healing Wound
  • Periodontitis

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Keywords

  • postoperative healing
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSimplified 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.

    Also known as: SPPF

  • ProcedureResective 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.

    Also known as: RPFO

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Period from pre-surgery to 90 days post-surgery

  2. 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).

    Time frame: 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

    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

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Study locations

1 site
  • Queen Mary University London
    London, E1 2AD, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03631693
Lead sponsor
Queen Mary University of London
Responsible party
Sponsor
First posted
Aug 15, 2018
Start date
Feb 21, 2018
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Feb 19, 2026

Study contacts

Nikos Donos, Prof.
study director · Institute of Dentistry, QMUL
Nikos Donos, Prof.
principal investigator · Institute of Dentistry, QMUL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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