Healing WoundNCT03631693
Imaging Analysis Following Periodontal Surgery
A study testing Simplified papilla preservation flap and Resective periodontal flap with osseous recontouring in people with Healing Wound and Periodontitis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Healing Wound, Periodontitis
- What is being tested?
- Simplified papilla preservation flap and Resective periodontal flap with osseous recontouring
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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.
- Conditions
- Healing Wound, Periodontitis
- Being tested
- Simplified papilla preservation flap, Resective periodontal flap with osseous recontouring
- Keywords
- postoperative healing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified papilla preservation flapProcedure or surgery
Also called SPPF
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 periodontal flap with osseous recontouringProcedure or surgery
Also called RPFO
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Resective periodontal flap with osseous recontouring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Period from pre-surgery to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Feb 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, randomised, single-blind, parallel-group clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikos Donos, Prof., Study director, Institute of Dentistry, QMULNikos Donos, Prof., Principal investigator, Institute of Dentistry, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631693
- Sponsor's protocol ID
- 17/LO/1428
- Status last verified
- Feb 2026
- First submitted
- 7 Jun 2018
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03631693
- Acronym / sponsor ID
- 17/LO/1428
- Conditions
- Healing Wound, Periodontitis
- Keywords
- postoperative healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single centre, randomised, single-blind, parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Simplified papilla preservation flap | Active comparator | Procedure: Simplified papilla preservation flapPERIODONTAL 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. |
| Resective flap with osseous recontouring | Active comparator | Procedure: Resective periodontal flap with osseous recontouringPERIODONTAL 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplified papilla preservation flapAlso: SPPFThe 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. | Procedure or surgery | Simplified papilla preservation flap |
| Resective periodontal flap with osseous recontouringAlso: RPFOThe 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. | Procedure or surgery | Resective flap with osseous recontouring |
Primary outcome
Geometrical (3D) imaging in post-periodontal surgery wound healing.
Time frame: Period from pre-surgery to 90 days post-surgery
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.
Time frame: Period from pre-surgery to 90 days post-surgery
Subtracted thermography images from the baseline will identify the change of the tissue temperature in the area of surgery (extra and intra orally).
1 secondary outcome
Patient related outcome measures (PROMs) particularly on oral health related quality of life
Time frame: Period from pre-surgery to 90 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikos Donos, Prof. study director
Institute of Dentistry, QMUL
Nikos Donos, Prof. principal investigator
Institute of Dentistry, QMUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified papilla preservation flap and Resective periodontal flap with osseous recontouring in people with Healing Wound and Periodontitis, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometrical (3D) imaging in post-periodontal surgery wound healing. (time frame: Period from pre-surgery to 90 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.