Periodontal DiseasesPhase 4NCT07119307
Papilla Preservation Technique in Combination With Tooth Enamel Proteins and Animal Derived Bone Graft in Treating Isolated Bone Defects Between Teeth
A Phase 4 study testing Entire Papilla Preservation Technique, Entire Papilla Preservation Surgical Technique (EPPT) alone and Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) in people with Periodontal Diseases and Intrabony Periodontal Defect, run by Rungta College of Dental Sciences and Research at 1 site in India.
Trial summary
The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Intrabony Periodontal Defect
- What is being tested?
- Entire Papilla Preservation Technique, Entire Papilla Preservation Surgical Technique (EPPT) alone and Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteIndia
- Study dates
- 30 May 2023to 30 Mar 2025
- Phase
- Phase 4
- 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
- stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects
- single-rooted teeth/multi-rooted teeth without furcation involvement
Who cannot join
- uncontrolled or poorly controlled diabetes,
- unstable or life-threatening conditions, or requiring antibiotic prophylaxis,
- History of use of medications since last 6 months (immunosuppressants and antibiotics),
- Subjects allergic to medications,
- Pregnant or lactating women, Smokers/users of other tobacco products,
- Subjects showing unacceptable oral hygiene maintenance after initial phase I therapy and
- multiple interconnected vertical defects.
Trial locations and contacts
1 site in 1 country.
India1 site
Rungta College of Dental Sciences and Research
Bhilai, Chhattisgarh, 490024
About this study
Official title: Evaluation of Entire Papilla Preservation Technique in Combination With Enamel Matrix Derivative & Bone Mineral Derived Xenograft in Isolated Interdental Intrabony Defects
The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.
Read the detailed description
This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.
- Conditions
- Periodontal Diseases, Intrabony Periodontal Defect
- Being tested
- Entire Papilla Preservation Technique, Entire Papilla Preservation Surgical Technique (EPPT) alone, Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire Papilla Preservation TechniqueProcedure or surgery
Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX)
Entire Papilla Preservation Surgical Technique (EPPT) aloneProcedure or surgery
Entire Papilla Preservation Surgical Technique (EPPT) alone
Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)Procedure or surgery
Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)
| Study group | Role | What they receive |
|---|---|---|
| Entire Papilla Preservation Technique | Placebo comparator | Entire Papilla Preservation Technique alone Receives: Procedure: Entire Papilla Preservation Technique |
| Entire Papilla Preservation Technique with Emdogain | Active comparator | Entire Papilla Preservation Technique with Emdogain Receives: Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone |
| Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft | Active comparator | Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft Receives: Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative attachment level gain
measuring relative attachment level gain with UNC-15 probe
Measured: 6 months
pocket depth change
measuring probing pocket depth changes
Measured: 6 months
Secondary outcomes (2)
Tomographic defect width
measured defect width in CBCT
Measured: 6 months
the distance between the cemento-enamel junction and the bottom of the defect
the distance between the cemento-enamel junction and the bottom of the defect
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start30 May 2023
- Primary completion30 Jan 2025
- Study completion30 Mar 2025
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 DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rungta College of Dental Sciences and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Krishna M, Rungta College of Dental Sciences and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119307
- Sponsor's protocol ID
- RCDSR/IEC/MDS/2023/D-35
- Status last verified
- May 2023
- First submitted
- 11 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For confidentiality
Publications
Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.
PubMed 28196163
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Entire Papilla Preservation Technique in Combination With Enamel Matrix Derivative & Bone Mineral Derived Xenograft in Isolated Interdental Intrabony Defects
- ClinicalTrials.gov ID
- NCT07119307
- Acronym / sponsor ID
- RCDSR/IEC/MDS/2023/D-35
- Conditions
- Periodontal Diseases, Intrabony Periodontal Defect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rungta College of Dental Sciences and ResearchUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 13 Aug 2025 (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 present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.
Detailed description
This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Entire Papilla Preservation Technique | Placebo comparator | Procedure: Entire Papilla Preservation TechniqueEntire Papilla Preservation Technique alone |
| Entire Papilla Preservation Technique with Emdogain | Active comparator | Procedure: Entire Papilla Preservation Surgical Technique (EPPT) aloneEntire Papilla Preservation Technique with Emdogain |
| Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft | Active comparator | Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects
- single-rooted teeth/multi-rooted teeth without furcation involvement
Key exclusion criteria (7 listed)
- uncontrolled or poorly controlled diabetes,
- unstable or life-threatening conditions, or requiring antibiotic prophylaxis,
- History of use of medications since last 6 months (immunosuppressants and antibiotics),
- Subjects allergic to medications,
- Pregnant or lactating women, Smokers/users of other tobacco products,
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 TechniqueEntire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX) | Procedure or surgery | Entire Papilla Preservation Technique |
| Entire Papilla Preservation Surgical Technique (EPPT) aloneEntire Papilla Preservation Surgical Technique (EPPT) alone | Procedure or surgery | Entire Papilla Preservation Technique with Emdogain |
| Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) | Procedure or surgery | Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft |
Primary outcome
relative attachment level gain
Time frame: 6 months
measuring relative attachment level gain with UNC-15 probe
pocket depth change
Time frame: 6 months
measuring probing pocket depth changes
2 secondary outcomes
Tomographic defect width
Time frame: 6 months
the distance between the cemento-enamel junction and the bottom of the defect
Time frame: 6 months
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 15 Sep 2025.
- Results publication: PubMed 28196163Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.
- Individual participant dataSharing planned: Undecided. For confidentiality
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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 Phase 4 study testing Entire Papilla Preservation Technique, Entire Papilla Preservation Surgical Technique (EPPT) alone and Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) in people with Periodontal Diseases and Intrabony Periodontal Defect, run by Rungta College of Dental Sciences and Research at 1 site in India.
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 2 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 15 Sep 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
relative attachment level gain (time frame: 6 months). The study lists 2 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 NCT07119307, 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 15 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.