Periodontal PocketNCT05460988
"Re-instrumentation vs Flap Surgery"
A study testing Flap surgery and Non surgical re-instrumentation in people with Periodontal Pocket and Periodontitis, run by University of Florence at 1 site in Italy.
Trial summary
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets. The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Pocket, Periodontitis
- What is being tested?
- Flap surgery and Non surgical re-instrumentation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 11 Aug 2022to 11 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18aa
- Patients with periodontal disease
- Less than 20 cigarettes/day
- No systemic antibiotic therapy in the last 3 months
- At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
- Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
- No previous periodontal surgery at the experimental tooth
Who cannot join
- Connective tissue diseases
- Diabetes
- Pregnancy or lactating
- Furcation involvement
- Crowned tooth
- Severe tooth mobility (class III)
- Radiographical horizontal bone resorption exceeding the 50% of the root
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.
The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
- Conditions
- Periodontal Pocket, Periodontitis
- Being tested
- Flap surgery, Non surgical re-instrumentation
- Keywords
- non-surgical periodontal therapy, re-instrumentation
- Medical subject headings
- Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flap surgeryProcedure or surgery
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
Non surgical re-instrumentationProcedure or surgery
The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
| Study group | Role | What they receive |
|---|---|---|
| Non surgical re-instrumentation | Experimental | The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes. Receives: Procedure: Non surgical re-instrumentation |
| Flap surgery | Active comparator | All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0). Receives: Procedure: Flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD change
change in periodontal probing depth (in mm)
Measured: 3 months after the procedure
PD change
change in periodontal probing depth (in mm)
Measured: 6 months after the procedure
PD change
change in periodontal probing depth (in mm)
Measured: 12 months after the procedure
Secondary outcomes (3)
CAL change
change in clinical attachment level (in mm)
Measured: 3 months after the procedure
CAL change
change in clinical attachment level (in mm)
Measured: 6 months after the procedure
CAL change
change in clinical attachment level (in mm)
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start11 Aug 2022
- Primary completion11 May 2023
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal PocketStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Barbato, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460988
- Sponsor's protocol ID
- 18876
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barbato L, Noce D, Di Martino M, Castelluzzo W, Spoleti F, Rupe C, Nieri M, Cairo F. Non-surgical retreatment versus papillary preservation flap surgery for residual pockets: A randomized controlled trial with clinical and patient-reported outcomes. J Clin Periodontol. 2024 Oct;51(10):1277-1288. doi: 10.1111/jcpe.14047. Epub 2024 Jul 16.
PubMed 39011585
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
- ClinicalTrials.gov ID
- NCT05460988
- Acronym / sponsor ID
- 18876
- Conditions
- Periodontal Pocket, Periodontitis
- Keywords
- non-surgical periodontal therapy, re-instrumentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 15 Jul 2022 (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.
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.
The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non surgical re-instrumentation | Experimental | Procedure: Non surgical re-instrumentationThe sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes. |
| Flap surgery | Active comparator | Procedure: Flap surgeryAll the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18aa
- Patients with periodontal disease
- Less than 20 cigarettes/day
- No systemic antibiotic therapy in the last 3 months
- At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
Key exclusion criteria (7 listed)
- Connective tissue diseases
- Diabetes
- Pregnancy or lactating
- Furcation involvement
- Crowned tooth
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 |
|---|---|---|
| Flap surgeryAll the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0). | Procedure or surgery | Flap surgery |
| Non surgical re-instrumentationThe sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes. | Procedure or surgery | Non surgical re-instrumentation |
Primary outcome
PD change
Time frame: 3 months after the procedure
change in periodontal probing depth (in mm)
PD change
Time frame: 6 months after the procedure
change in periodontal probing depth (in mm)
PD change
Time frame: 12 months after the procedure
change in periodontal probing depth (in mm)
3 secondary outcomes
CAL change
Time frame: 3 months after the procedure
CAL change
Time frame: 6 months after the procedure
CAL change
Time frame: 12 months after the procedure
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 10 Apr 2025.
- Derived from this study: PubMed 39011585Barbato L, Noce D, Di Martino M, Castelluzzo W, Spoleti F, Rupe C, Nieri M, Cairo F. Non-surgical retreatment versus papillary preservation flap surgery for residual pockets: A randomized controlled trial with clinical and patient-reported outcomes. J Clin Periodontol. 2024 Oct;51(10):1277-1288. doi: 10.1111/jcpe.14047. Epub 2024 Jul 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flap surgery and Non surgical re-instrumentation in people with Periodontal Pocket and Periodontitis, run by University of Florence at 1 site in Italy.
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 7 inclusion and 7 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 10 Apr 2025. 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 Italy. 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?
PD change (time frame: 3 months after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460988, which also lists 1 linked publication.
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 10 Apr 2025.