Periodontal PocketNCT05533528
Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
A study testing periodontal surgery in people with Periodontal Pocket and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Pocket, Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- periodontal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2022to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Stage III or IV periodontitis, including all grades.
- Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
- Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
- Adherence to periodontal maintenance appointments.
Who cannot join
- Systemic disease contraindicating periodontal surgery.
- Teeth with incorrect endodontic treatment or restoration.
- Stage I or II periodontitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro Odontologico Del Sureste Slp
Murcia, 30007
Antonio J Ortiz-Ruiz, MD, +34 868888581, ajortiz@um.es
Jose A Moreno-Rodriguez, +34 620538483, joseantonio171087@hotmail.com
About this study
Official title: Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.
The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).
Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).
- Being tested
- periodontal surgery
- Medical subject headings
- Periodontal Pocket, Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal surgeryProcedure or surgery
A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Access flap periodontal surgery Receives: Procedure: periodontal surgery |
| Test | Experimental | Access flap periodontal surgery and periodontal granulation tissue debridement. Receives: Procedure: periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment gain (CAG)
Clinical attachment gain
Measured: 12 months
Secondary outcomes (5)
rPD
residual probing depth
Measured: 12 months
PPDr
Probing pocket depth reduction
Measured: 12 months
iGR
interproximal gingival recession
Measured: 12 months
Early Healing Index (EHI)
Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively.
Measured: 1 week
SUPRA-AG
Supra-alveolar attachment gain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start3 May 2022
- Primary completion22 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio José Ortiz Ruiz, MD, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533528
- Sponsor's protocol ID
- 3111/2020
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2022
- Last updated
- 19 Feb 2026
- Results posted
- 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
- Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05533528
- Acronym / sponsor ID
- 3111/2020
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Sep 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.
The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.
The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).
Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: periodontal surgeryAccess flap periodontal surgery |
| Test | Experimental | Procedure: periodontal surgeryAccess flap periodontal surgery and periodontal granulation tissue debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage III or IV periodontitis, including all grades.
- Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
- Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
- Adherence to periodontal maintenance appointments.
Key exclusion criteria (3 listed)
- Systemic disease contraindicating periodontal surgery.
- Teeth with incorrect endodontic treatment or restoration.
- Stage I or II periodontitis.
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 |
|---|---|---|
| periodontal surgeryA sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured. | Procedure or surgery | Control, Test |
Primary outcome
Clinical attachment gain (CAG)
Time frame: 12 months
Clinical attachment gain
5 secondary outcomes
rPD
Time frame: 12 months
PPDr
Time frame: 12 months
iGR
Time frame: 12 months
Early Healing Index (EHI)
Time frame: 1 week
SUPRA-AG
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- A pilot prospective study on the periodontal granulation tissue preservation in surgical periodontal disease treatmentLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal surgery in people with Periodontal Pocket and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
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 3 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: looking for participants now, 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio J Ortiz-Ruiz, MD (+34 868888581, ajortiz@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment gain (CAG) (time frame: 12 months). 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.