PeriodontitisMEPPTNCT05029089
Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.
A study testing Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG) and Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect in people with Periodontitis and Regeneration, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Regeneration
- What is being tested?
- Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG) and Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 10 Sep 2021to 1 Sep 2023
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years (age 18-60 years), both genders
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated intrabony defect of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis)
- The area of the intrabony defect should not exceed the lingual surface area of the root
- The morphology of the intrabony defect will be detected during the operation and finally determined whether the patient would be enrolled in the trial.
- 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 index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
Show all 10Show fewer
- Previous periodontal surgery in the examined area
- Affected teeth with 3° mobility
- Furcation involvement
- Acute periapical inflammation
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, 00-246
Batlomiej Gorski, DDS, PhD, +48 22 502 20 99
About this study
Official title: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. A Randomized Clinical Trial.
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae.
This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.
Read the detailed description
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Both resorbable and nonresorbable barrier membranes have been widely used to receive periodontal regeneration, as well as different types of biomaterial have been investigated. Enamel matrix derivative (EMD, Emdogain, Straumann) become popular for periodontal regeneration, especially that membrane exposure due to bacterial contamination may deteriorate periodontal regeneration and wound healing especially in the interproximal areas. Hence different surgical procedures have been proposed to preserve interdental papilla. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae by providing a tunnel- like undermining incision.
The completely preserved papillae improve wound healing process, stabilize the blood clot and the volume of interdental tissue. EMD and bone substitutes (allograft) are applied in the defect to promote periodontal regeneration. By using subepithelial connective tissue graft (sCTG) better quality (thickness) of soft tissue can be achieved. This clinical report describes surgical approach using modified papilla preservation technique for regenerative periodontal therapy. This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.
- Conditions
- Periodontitis, Regeneration
- Being tested
- Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG), Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect, Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect, Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect
- Keywords
- Papilla Preservation Technique, Regenerative Treatment, Allograft, Emdogain
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.Procedure or surgery
Surgical approach using modified papilla preservation technique for regenerative periodontal therapy.
Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)Device
Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy.
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony DefectProcedure or surgery
Surgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy.
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony DefectProcedure or surgery
Surgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy.
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony DefectProcedure or surgery
Surgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Entire Papilla Preservation Modified Technique (EPPMT) | Experimental | Procedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated (subperiosteal tunnel). Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. Microsurgical suturing technique with 7-0 materials was performed. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. Receives: Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. |
| Entire Papilla Preservation Modified Technique + EMD | Active comparator | Procedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. 24%EDTA was applied on the exposed root surface for 2 minutes, than rinsed and EMD was applied. Vertical incision was closed with simple single sutures(7-0),whereas due to modification of the original technique additional sling suture was applied. Receives: Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.; Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG); Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect |
| EPP Modified Technique+EMD+allograft | Active comparator | Procedure:The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. Receives: Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.; Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG); Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect; Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect |
| EPP Modified Technique+EMD+allograft+sCTG | Active comparator | Procedure: After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. sCTG taken form palate was sutured to the inner part of mucosa flap. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. Receives: Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.; Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG); Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect; Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect; Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal parameters measured before surgery.
- Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus
- Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus
- Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin
- Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction
- Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
Measured: 1-7 days before surgery
Periodontal parameters measured during surgery.
- Intrabony component defects architecture after debridement MEASURED IN MILIMETERS(depth: distance between the crest of the marginal bone and the deepest location of the osseous defect, width: horizontal distance from the root surface to the alveolar bone crest).
- CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect MEASURED IN MILIMETERS
Measured: During surgery
Periodontal parameters measured on basis of X-ray
- CEJ-MB: distance between cementoenamel junction (CEJ) and the crest of the marginal bone (MB) MEASURED IN MILIMETERS
- CEJ- BD: distance between cementoenamel junction (CEJ) and the bottom of the defect (BD) MEASURED IN MILIMETERS
Measured: 1-7 days before surgery
Secondary outcomes (1)
Periodontal parameters measured after surgery.
- Probing pocket depth (PPD): distance from the gingival margin to the bottom of the gingival sulcus
- Clinical attachment level (CAL): distance from the cementoenamel junction to the bottom of the gingival sulcus
- Recession height (RH): distance from the cementoenamel junction to the gingival margin
- Width of keratinized tissue (WKT): distance between the most apical point of the gingival margin and the mucogingival junction
- Gingival thickness (GT): thickness of the gingiva measured 2-3 mm apical to the gingival margin
- Radiographic evaluation:
- Radiographical bone- filling of the intrabony defect
- CEJ- MB: distance between cementoenamel junction and the crest of the marginal bone
- CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect
ALL ABOVE PARAMETERS ARE MEASURED IN MILIMETERS
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 Sep 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
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 PeriodontitisStudies 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
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata Górska, Professor, Study chair, Department of Periodontal and Oral Mucosa Diseases in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029089
- Sponsor's protocol ID
- WUM.Perio.04
- Acronym
- MEPPT
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gorski B, Jakubowska S, Wyrebek B. Entire Papilla Preservation Technique with Enamel Matrix Proteins and Allogenic Bone Substitutes for the Treatment of Isolated Intrabony Defects: A 3-Year Follow-Up of a Prospective Case Series. J Clin Med. 2025 Mar 30;14(7):2374. doi: 10.3390/jcm14072374.
PubMed 40217825
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05029089
- Acronym / sponsor ID
- MEPPT / WUM.Perio.04
- Conditions
- Periodontitis, Regeneration
- Keywords
- Papilla Preservation Technique, Regenerative Treatment, Allograft, Emdogain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 31 Aug 2021 (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.
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae.
This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.
Detailed description
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Both resorbable and nonresorbable barrier membranes have been widely used to receive periodontal regeneration, as well as different types of biomaterial have been investigated. Enamel matrix derivative (EMD, Emdogain, Straumann) become popular for periodontal regeneration, especially that membrane exposure due to bacterial contamination may deteriorate periodontal regeneration and wound healing especially in the interproximal areas. Hence different surgical procedures have been proposed to preserve interdental papilla. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae by providing a tunnel- like undermining incision.
The completely preserved papillae improve wound healing process, stabilize the blood clot and the volume of interdental tissue. EMD and bone substitutes (allograft) are applied in the defect to promote periodontal regeneration. By using subepithelial connective tissue graft (sCTG) better quality (thickness) of soft tissue can be achieved. This clinical report describes surgical approach using modified papilla preservation technique for regenerative periodontal therapy. This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Entire Papilla Preservation Modified Technique (EPPMT) | Experimental | Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.Procedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated (subperiosteal tunnel). Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. Microsurgical suturing technique with 7-0 materials was performed. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. |
| Entire Papilla Preservation Modified Technique + EMD | Active comparator | Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG), Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony DefectProcedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. 24%EDTA was applied on the exposed root surface for 2 minutes, than rinsed and EMD was applied. Vertical incision was closed with simple single sutures(7-0),whereas due to modification of the original technique additional sling suture was applied. |
| EPP Modified Technique+EMD+allograft | Active comparator | Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG), Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect, Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony DefectProcedure:The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. |
| EPP Modified Technique+EMD+allograft+sCTG | Active comparator | Procedure: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Device: Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG), Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect, Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect, Procedure: Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony DefectProcedure: After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. sCTG taken form palate was sutured to the inner part of mucosa flap. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years (age 18-60 years), both genders
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated intrabony defect of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis)
- The area of the intrabony defect should not exceed the lingual surface area of the root
Key exclusion criteria (10 listed)
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / 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 |
|---|---|---|
| Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.Surgical approach using modified papilla preservation technique for regenerative periodontal therapy. | Procedure or surgery | EPP Modified Technique+EMD+allograft, EPP Modified Technique+EMD+allograft+sCTG, Entire Papilla Preservation Modified Technique + EMD, Experimental: Entire Papilla Preservation Modified Technique (EPPMT) |
| Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy. | Device | EPP Modified Technique+EMD+allograft, EPP Modified Technique+EMD+allograft+sCTG, Entire Papilla Preservation Modified Technique + EMD |
| Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony DefectSurgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy. | Procedure or surgery | EPP Modified Technique+EMD+allograft, EPP Modified Technique+EMD+allograft+sCTG, Entire Papilla Preservation Modified Technique + EMD |
| Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony DefectSurgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy. | Procedure or surgery | EPP Modified Technique+EMD+allograft, EPP Modified Technique+EMD+allograft+sCTG |
| Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony DefectSurgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy. | Procedure or surgery | EPP Modified Technique+EMD+allograft+sCTG |
Primary outcome
Periodontal parameters measured before surgery.
Time frame: 1-7 days before surgery
1. Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
Periodontal parameters measured during surgery.
Time frame: During surgery
1. Intrabony component defects architecture after debridement MEASURED IN MILIMETERS(depth: distance between the crest of the marginal bone and the deepest location of the osseous defect, width: horizontal distance from the root surface to the alveolar bone crest). 2. CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect MEASURED IN MILIMETERS
Periodontal parameters measured on basis of X-ray
Time frame: 1-7 days before surgery
1. CEJ-MB: distance between cementoenamel junction (CEJ) and the crest of the marginal bone (MB) MEASURED IN MILIMETERS 2. CEJ- BD: distance between cementoenamel junction (CEJ) and the bottom of the defect (BD) MEASURED IN MILIMETERS
1 secondary outcome
Periodontal parameters measured after surgery.
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 40217825Gorski B, Jakubowska S, Wyrebek B. Entire Papilla Preservation Technique with Enamel Matrix Proteins and Allogenic Bone Substitutes for the Treatment of Isolated Intrabony Defects: A 3-Year Follow-Up of a Prospective Case Series. J Clin Med. 2025 Mar 30;14(7):2374. doi: 10.3390/jcm14072374.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Renata Górska, Professor study chair
Department of Periodontal and Oral Mucosa Diseases in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects., Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG) and Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect in people with Periodontitis and Regeneration, run by Medical University of Warsaw at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beata Wyrębek, PhD (+48692013589, beatawyrebek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal parameters measured before surgery. (time frame: 1-7 days before surgery). 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 NCT05029089, 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 12 Oct 2021.