Intrabony Periodontal DefectEWH_regNCT07683962
Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery
An observational study of Intrabony Periodontal Defect and Wound Healing, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrabony Periodontal Defect, Wound Healing
- What is being tested?
- Periodontal Regenerative Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2026to 1 Oct 2027
- Phase
- Observational
- 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
Study population: The study population consists of adult patients (age >=18) diagnosed with Stage III or IV Periodontitis according to the 2017 World Workshop Classification. These patients present with at least one deep interproximal infrabony defect requiring regenerative surgical treatment. Participants are recruited from the patient pool of the Section of Periodontics at Sapienza University of Rome, Italy. The population includes both systemically healthy individuals and those with well-controlled systemic conditions (ASA I or II), who have maintained optimal oral hygiene (FMPS/FMBS < 15%) following initial non-surgical periodontal therapy.
Who may be able to join
- Diagnosis of Stage III or IV Periodontitis.
- Presence of at least one deep interproximal infrabony defect (Probing Pocket Depth [PPD] >= 6 mm, radiographic depth >= 3 mm).
- Optimal oral hygiene: Full-Mouth Plaque Score (FMPS) and Full-Mouth Bleeding Score (FMBS) < 15% at the time of surgery.
Who cannot join
- Systemic: ASA III-VI classification; uncontrolled diabetes; medications causing gingival overgrowth (e.g., nifedipine, cyclosporine, phenytoin); heavy smokers (>10 cigarettes/day); pregnancy or lactation.
- Local: Third molars; Grade III tooth mobility; inadequate endodontic treatment; teeth undergoing orthodontic treatment; teeth supporting removable or implant-linked fixed prosthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
Rome, Rome, 00161
Andrea Pilloni, +39 3356409374, andrea.pilloni@uniroma1.it
About this study
Official title: Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study
This study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV periodontitis.
Read the detailed description
This single-center, prospective observational cohort study addresses two pre-specified aims: (1) the association between early wound healing at 1 and 2 weeks and 12-month clinical and radiographic outcomes; and (2) the identification of patient-related, site-related (e.g., intrabony defect depth, CEJ-to-bone-crest distance, defect configuration, intrabony defect classification), and technique-related (flap design, biomaterial) factors associated with optimal early wound healing.
- Conditions
- Intrabony Periodontal Defect, Wound Healing
- Being tested
- Periodontal Regenerative Therapy
- Keywords
- periodontal regeneration, early wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Regenerative TherapyProcedure or surgery
All subjects undergo surgical debridement of the intrabony defect followed by a regenerative approach (biologics with or without bone grafts, or blood clot alone) using papilla preservation techniques (MIST, M-MIST, MPPT, SPPF, or SFA).
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Regeneration Cohort | This single cohort consists of patients with Stage III-IV periodontitis presenting at least one deep vertical infrabony defect. All patients receive periodontal regenerative surgery according to clinical indications. The cohort will be subsequently stratified into subgroups during data analysis based on the early wound healing assessment at 1 and 2 weeks to evaluate the impact of healing quality on 12-month clinical attachment level (CAL) and radiographic outcomes and to identify patient-related, site-specific, and/or technique-related factors associated with optimal early wound healing, Receives: Procedure: Periodontal Regenerative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL).
Measured: Baseline and 12 months.
Secondary outcomes (8)
Composite healing index (CHI)
CHI has two independent, dichotomous domains (wound closure and wound quality), each answering a single clinically distinct question, and reports the outcome as a two-digit composite code.
Measured: 1 and 2 weeks
Probing Pocket Depth (PPD) Change:
Measured: Baseline and 12 months.
Early Wound Healing Index (EHI)
Assessed using the Early Wound Healing Index (EHI). The index ranges from a minimum score of 1 (complete tissue closure without fibrin) to a maximum score of 5 (incomplete tissue closure with partial/complete necrosis). Higher scores mean a worse clinical outcome.
Measured: 1 and 2 weeks
Change in Radiographic Parameters
Measured in millimeters (mm) or degrees (°) on standardized radiographs from baseline to 12 months. It calculates the distance from a fixed reference point (e.g., cementoenamel junction) to the bottom of the bony defect. A positive change (increase in mm) indicates bone gain (better outcome).
Measured: Baseline and 12 months.
Number of analgesic tablets
Measured: 1 and 2 weeks
Percentage of Sites With Bleeding on Probing (BOP)
Presence or absence of bleeding assessed within 30 seconds of probing at specific sites. The data will be aggregated and reported as the percentage of sites showing bleeding out of the total sites examined. Higher percentages indicate worse outcomes.
Measured: Baseline and 12 months
Composite outcome measure (COM)
Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm
Measured: 12 months
Pocket closure
Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing
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 posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilloni MD DDS MS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683962
- Sponsor's protocol ID
- 8328
- Acronym
- EWH_reg
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07683962
- Acronym / sponsor ID
- EWH_reg / 8328
- Conditions
- Intrabony Periodontal Defect, Wound Healing
- Keywords
- periodontal regeneration, early wound healing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 6 Jul 2026 (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 study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV periodontitis.
Detailed description
This single-center, prospective observational cohort study addresses two pre-specified aims: (1) the association between early wound healing at 1 and 2 weeks and 12-month clinical and radiographic outcomes; and (2) the identification of patient-related, site-related (e.g., intrabony defect depth, CEJ-to-bone-crest distance, defect configuration, intrabony defect classification), and technique-related (flap design, biomaterial) factors associated with optimal early wound healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontal Regeneration Cohort | – | Procedure: Periodontal Regenerative TherapyThis single cohort consists of patients with Stage III-IV periodontitis presenting at least one deep vertical infrabony defect. All patients receive periodontal regenerative surgery according to clinical indications. The cohort will be subsequently stratified into subgroups during data analysis based on the early wound healing assessment at 1 and 2 weeks to evaluate the impact of healing quality on 12-month clinical attachment level (CAL) and radiographic outcomes and to identify patient-related, site-specific, and/or technique-related factors associated with optimal early wound healing, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (age >=18) diagnosed with Stage III or IV Periodontitis according to the 2017 World Workshop Classification. These patients present with at least one deep interproximal infrabony defect requiring regenerative surgical treatment. Participants are recruited from the patient pool of the Section of Periodontics at Sapienza University of Rome, Italy. The population includes both systemically healthy individuals and those with well-controlled systemic conditions (ASA I or II), who have maintained optimal oral hygiene (FMPS/FMBS < 15%) following initial non-surgical periodontal therapy.
Key inclusion criteria (3 listed)
- Diagnosis of Stage III or IV Periodontitis.
- Presence of at least one deep interproximal infrabony defect (Probing Pocket Depth [PPD] >= 6 mm, radiographic depth >= 3 mm).
- Optimal oral hygiene: Full-Mouth Plaque Score (FMPS) and Full-Mouth Bleeding Score (FMBS) < 15% at the time of surgery.
Key exclusion criteria (2 listed)
- Systemic: ASA III-VI classification; uncontrolled diabetes; medications causing gingival overgrowth (e.g., nifedipine, cyclosporine, phenytoin); heavy smokers (>10 cigarettes/day); pregnancy or lactation.
- Local: Third molars; Grade III tooth mobility; inadequate endodontic treatment; teeth undergoing orthodontic treatment; teeth supporting removable or implant-linked fixed prosthetics.
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 Regenerative TherapyAll subjects undergo surgical debridement of the intrabony defect followed by a regenerative approach (biologics with or without bone grafts, or blood clot alone) using papilla preservation techniques (MIST, M-MIST, MPPT, SPPF, or SFA). | Procedure or surgery | Periodontal Regeneration Cohort |
Primary outcome
Change in Clinical Attachment Level (CAL).
Time frame: Baseline and 12 months.
8 secondary outcomes
Composite healing index (CHI)
Time frame: 1 and 2 weeks
Probing Pocket Depth (PPD) Change:
Time frame: Baseline and 12 months.
Early Wound Healing Index (EHI)
Time frame: 1 and 2 weeks
Change in Radiographic Parameters
Time frame: Baseline and 12 months.
Number of analgesic tablets
Time frame: 1 and 2 weeks
Percentage of Sites With Bleeding on Probing (BOP)
Time frame: Baseline and 12 months
Composite outcome measure (COM)
Time frame: 12 months
Pocket closure
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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Intrabony Periodontal Defect and Wound Healing, run by University of Roma La Sapienza 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 3 inclusion and 2 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 31 Jul 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 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?
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 Andrea Pilloni (+39 3356409374, andrea.pilloni@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Level (CAL). (time frame: Baseline and 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 31 Jul 2026.