Intrabony Periodontal DefectNCT07737834
Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
A study testing Entire Papilla Preservation Technique (EPPT), EDTA root conditioning and Enamel Matrix Derivative (EMD)- Emdogain in people with Intrabony Periodontal Defect, run by Medical University of Warsaw at 3 sites in Poland.
Trial summary
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Entire Papilla Preservation Technique (EPPT), EDTA root conditioning and Enamel Matrix Derivative (EMD)- Emdogain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesPoland
- Study dates
- 1 Aug 2026to 30 Nov 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
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
Who cannot join
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
- Pregnant and lactating females
Show all 10Show fewer
- Previous periodontal surgery in the examined area
- III-degree mobility
- Furcation involvement
- Pulpal pathology or inadequate endodontic treatment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites
Department of Integrated Dentistry, University of Białystok
Bialystok, 15276
Anna Skurska, annaskurska@wp.pl
Department of Periodontology, Pomeranian Medical University Contact
Szczecin
Monika Machoy, monika.machoy@pum.edu.pl
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Warsaw, 00-246
About this study
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
Read the detailed description
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Entire Papilla Preservation Technique (EPPT), EDTA root conditioning, Enamel Matrix Derivative (EMD)- Emdogain, Subepithelial Connective Tissue Graft (SCTG), Bone substitute - Bio Oss Collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire Papilla Preservation Technique (EPPT)Procedure or surgery
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla. The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
EDTA root conditioningOther
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Enamel Matrix Derivative (EMD)- EmdogainDrug
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Subepithelial Connective Tissue Graft (SCTG)Procedure or surgery
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
Bone substitute - Bio Oss CollagenOther
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
| Study group | Role | What they receive |
|---|---|---|
| Entire Papilla Preservation Technique (EPPT) + EMD | Active comparator | Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed. Flaps are repositioned and sutured for primary closure. Receives: Procedure: Entire Papilla Preservation Technique (EPPT); Other: EDTA root conditioning; Drug: Enamel Matrix Derivative (EMD)- Emdogain; Other: Bone substitute - Bio Oss Collagen |
| Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG | Experimental | Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material. A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure. Receives: Procedure: Entire Papilla Preservation Technique (EPPT); Other: EDTA root conditioning; Drug: Enamel Matrix Derivative (EMD)- Emdogain; Procedure: Subepithelial Connective Tissue Graft (SCTG); Other: Bone substitute - Bio Oss Collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level gain (CAL, mm)
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Measured: 6 months and 12 months
Secondary outcomes (12)
Probing Pocket Depth (PPD, mm)
Probing Pocket Depth (PPD), measured in millimeters (mm), defined as the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Measured: Baseline, 6 months and 12 months
Probing Pocket Depth reduction (PPD, mm)
Probing Pocket Depth (PPD) reduction, measured in millimeters (mm), defined as the change from baseline in the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Measured: 6 months and 12 months
Clinical Attachment Level (CAL, mm)
Clinical Attachment Level (CAL), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Measured: Baseline, 6 months, and 12 months
Gingival Recession (GR, mm)
Gingival recession (GR), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the gingival margin, assessed using a calibrated periodontal probe.
Measured: Baseline, 6 months and 12 months
Keratinized Tissue Width (KTW, mm)
Keratinized tissue width (KTW), measured in millimeters (mm), defined as the distance from the gingival margin to the mucogingival junction, assessed using a periodontal probe.
Measured: Baseline, 6 months and 12 months
Gingival Thickness (GT, mm)
Gingival thickness (GT), measured in millimeters (mm) at the buccal aspect 3 mm apical to the gingival margin using a standardized transgingival probing method with an endodontic file and stopper.
Measured: Baseline, 6 months and 12 months
Soft Tissue Volumetric Change (mm³)
Change from baseline in soft tissue volume, expressed in cubic millimeters (mm³), assessed by superimposition of digital intraoral scans (STL files) using dedicated software with standardized reference areas.
Measured: 6 months and 12 months
Radiographic Linear Defect Fill (LDF, mm)
Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
Measured: 6 months and 12 months
Radiographic Percentage Defect Fill (%DF)
Percentage defect fill (%DF), expressed as a percentage (%), calculated based on standardized measurements obtained from periapical radiographs using a reproducible measurement protocol to assess bone defect resolution.
Measured: 6 months and 12 months
Early Wound Healing Score (EHS)
Early wound healing will be assessed using the Early Wound Healing Score (EHS), a composite clinical index ranging from 0 to 10 based on re-epithelialization, hemostasis, and inflammation, with higher scores indicating better healing.
Measured: 1 week and 2 weeks
Full-Mouth Plaque Score (FMPS, %)
Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
Measured: Baseline, 6 months, and 12 months
Full-Mouth Bleeding Score (FMBS, %)
Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 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 Medical University of WarsawThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartłomiej Górski, Study chair, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737834
- Sponsor's protocol ID
- Perio.06
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
- ClinicalTrials.gov ID
- NCT07737834
- Acronym / sponsor ID
- Perio.06
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 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 is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
Detailed description
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entire Papilla Preservation Technique (EPPT) + EMD | Active comparator | Procedure: Entire Papilla Preservation Technique (EPPT), Other: EDTA root conditioning, Drug: Enamel Matrix Derivative (EMD)- Emdogain, Other: Bone substitute - Bio Oss CollagenParticipants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed. Flaps are repositioned and sutured for primary closure. |
| Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG | Experimental | Procedure: Entire Papilla Preservation Technique (EPPT), Other: EDTA root conditioning, Drug: Enamel Matrix Derivative (EMD)- Emdogain, Procedure: Subepithelial Connective Tissue Graft (SCTG), Other: Bone substitute - Bio Oss CollagenParticipants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material. A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
Key exclusion criteria (10 listed)
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
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 |
|---|---|---|
| Entire Papilla Preservation Technique (EPPT)A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla. The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure. | Procedure or surgery | Entire Papilla Preservation Technique (EPPT) + EMD, Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG |
| EDTA root conditioningApplication of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes. | Other | Entire Papilla Preservation Technique (EPPT) + EMD, Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG |
| Enamel Matrix Derivative (EMD)- EmdogainA biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration. | Drug | Entire Papilla Preservation Technique (EPPT) + EMD, Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG |
| Subepithelial Connective Tissue Graft (SCTG)An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability. | Procedure or surgery | Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG |
| Bone substitute - Bio Oss CollagenA xenogeneic bone graft material used to support bone regeneration within the intrabony defect. | Other | Entire Papilla Preservation Technique (EPPT) + EMD, Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG |
Primary outcome
Clinical Attachment Level gain (CAL, mm)
Time frame: 6 months and 12 months
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
12 secondary outcomes
Probing Pocket Depth (PPD, mm)
Time frame: Baseline, 6 months and 12 months
Probing Pocket Depth reduction (PPD, mm)
Time frame: 6 months and 12 months
Clinical Attachment Level (CAL, mm)
Time frame: Baseline, 6 months, and 12 months
Gingival Recession (GR, mm)
Time frame: Baseline, 6 months and 12 months
Keratinized Tissue Width (KTW, mm)
Time frame: Baseline, 6 months and 12 months
Gingival Thickness (GT, mm)
Time frame: Baseline, 6 months and 12 months
Soft Tissue Volumetric Change (mm³)
Time frame: 6 months and 12 months
Radiographic Linear Defect Fill (LDF, mm)
Time frame: 6 months and 12 months
Radiographic Percentage Defect Fill (%DF)
Time frame: 6 months and 12 months
Early Wound Healing Score (EHS)
Time frame: 1 week and 2 weeks
Full-Mouth Plaque Score (FMPS, %)
Time frame: Baseline, 6 months, and 12 months
Full-Mouth Bleeding Score (FMBS, %)
Time frame: Baseline, 6 months, and 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 30 Jul 2026.
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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.
Bartłomiej Górski study chair
Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entire Papilla Preservation Technique (EPPT), EDTA root conditioning and Enamel Matrix Derivative (EMD)- Emdogain in people with Intrabony Periodontal Defect, run by Medical University of Warsaw at 3 sites in Poland.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 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 3 sites in Poland. 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 Małgorzata Wyszyńska-Pomian (+48 504006984, malgorzata.wyszynska@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level gain (CAL, mm) (time frame: 6 months 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 30 Jul 2026.