Periodontal DiseasesEPPNCT06744348
Entire Papilla Preservation Technique in the Treatment of Periodontal IntraBony Defects: a 1-year Follow-up Study
An observational study of Periodontal Diseases and Periodontal Bone Loss, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the radiographic and clinical outcomes associated with the whole papilla preservation technique in the treatment of isolated intraosseous defects in patients with stage III periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- ENTİRE PAPİLLA PRESERVATİON
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jul 2024to 15 Dec 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The aim of this study was to evaluate the data of 17 systemically healthy patients (12 males and 5 females) aged between 22 and 60 years (mean age 41.5 ± 5.96 years) who underwent a surgical procedure three months after completion of non-surgical periodontal therapy (NSPT).
Who may be able to join
- • Systemically healthy individuals.
- Patients who underwent reconstructive periodontal surgery following the completion of non-surgical treatment.
- Presence of at least one isolated two- or three-wall intrabony defect with probing depth (PD) ≥7 mm, clinical attachment level (CAL) ≥7 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth
- Full-mouth plaque score (FMPS) and full-mouth bleeding score ≤20%
Who cannot join
- Individuals who smoke
- Individuals with uncontrolled systemic disease
- Individuals using drugs that affect periodontal tissues
- Individuals during pregnancy and breastfeeding
- Presence of single-walled intraosseous defects
- Flood restoration
- Inadequate endodontic treatment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Konya Necmettin Erbakan Üniversitesi
Konya, Meram, 42090
Konya Necmettin Erbakan Üniversitesi
Konya, 42090
About this study
Official title: Entire Papilla Preservation Technique in the Treatment of Periodontal Intra-Bony Defects: a One-Year Clinical Follow-Up Study on Its Efficacy and Outcomes
The aim of this study was to investigate the radiographic and clinical outcomes associated with the whole papilla preservation technique in the treatment of isolated intraosseous defects in patients with stage III periodontitis. The records of 17 systemically healthy patients (12 women and 5 men) diagnosed with stage III periodontitis who underwent the whole papilla preservation technique three months after nonsurgical periodontal treatment were evaluated. The following clinical parameters were recorded at baseline and after treatment: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL) and gingival recession (GR). The early healing index (EHI) score was assessed 1 week after surgery in both groups. CAL gain was determined as the primary outcome. Baseline data as well as follow-up assessments at 1 month, 3 months, 6 months and 1 year were analyzed to determine the efficacy and long-term outcomes of the treatment.
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Being tested
- ENTİRE PAPİLLA PRESERVATİON
- Keywords
- microsurgery, clinical attachment level
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENTİRE PAPİLLA PRESERVATİONProcedure or surgery
The "EPP" technique is a tunnel-like approach of the defect-associated inter-dental papilla. Surgical loupes (3.3× magnification) with LED light illumination were used to increase visibility of the surgical site. Following a buccal intra-crevicular incision, a bevelled vertical releasing incision was performed in the buccal gingiva of the neighbouring inter-dental space and extended just beyond the mucogingival line to provide appropriate mechanical access to the intrabony defect.
| Study group | Role | What they receive |
|---|---|---|
| Entire Papila Preservation Tecnique | This innovative approach allows for vertical access to the defect site from the buccal and lingual sides without making incisions in the papillary region. Its goal is to minimize the risk of wound healing failure and the exposure of regenerative biomaterials by fully preserving the interdental papilla over the bony defect Receives: Procedure: ENTİRE PAPİLLA PRESERVATİON |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROBİNG DEPTH
Probing Depth (PD) refers to the distance from the gingival margin to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value
Measured: 1 YEARS
Clinical Attachment Level
Clinical Attachment Level (CAL) is defined as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Measured: 1 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start25 Jul 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uçan Yarkaç, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744348
- Sponsor's protocol ID
- 2024/470
- Acronym
- EPP
- Status last verified
- Aug 2024
- First submitted
- 2 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entire Papilla Preservation Technique in the Treatment of Periodontal Intra-Bony Defects: a One-Year Clinical Follow-Up Study on Its Efficacy and Outcomes
- ClinicalTrials.gov ID
- NCT06744348
- Acronym / sponsor ID
- EPP / 2024/470
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Keywords
- microsurgery, clinical attachment level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 20 Dec 2024 (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 aim of this study was to investigate the radiographic and clinical outcomes associated with the whole papilla preservation technique in the treatment of isolated intraosseous defects in patients with stage III periodontitis. The records of 17 systemically healthy patients (12 women and 5 men) diagnosed with stage III periodontitis who underwent the whole papilla preservation technique three months after nonsurgical periodontal treatment were evaluated. The following clinical parameters were recorded at baseline and after treatment: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL) and gingival recession (GR). The early healing index (EHI) score was assessed 1 week after surgery in both groups. CAL gain was determined as the primary outcome. Baseline data as well as follow-up assessments at 1 month, 3 months, 6 months and 1 year were analyzed to determine the efficacy and long-term outcomes of the treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire Papila Preservation Tecnique | – | Procedure: ENTİRE PAPİLLA PRESERVATİONThis innovative approach allows for vertical access to the defect site from the buccal and lingual sides without making incisions in the papillary region. Its goal is to minimize the risk of wound healing failure and the exposure of regenerative biomaterials by fully preserving the interdental papilla over the bony defect |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of this study was to evaluate the data of 17 systemically healthy patients (12 males and 5 females) aged between 22 and 60 years (mean age 41.5 ± 5.96 years) who underwent a surgical procedure three months after completion of non-surgical periodontal therapy (NSPT).
Key inclusion criteria (4 listed)
- • Systemically healthy individuals.
Key exclusion criteria (7 listed)
- Individuals who smoke
- Individuals with uncontrolled systemic disease
- Individuals using drugs that affect periodontal tissues
- Individuals during pregnancy and breastfeeding
- Presence of single-walled intraosseous defects
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 |
|---|---|---|
| ENTİRE PAPİLLA PRESERVATİONThe "EPP" technique is a tunnel-like approach of the defect-associated inter-dental papilla. Surgical loupes (3.3× magnification) with LED light illumination were used to increase visibility of the surgical site. Following a buccal intra-crevicular incision, a bevelled vertical releasing incision was performed in the buccal gingiva of the neighbouring inter-dental space and extended just beyond the mucogingival line to provide appropriate mechanical access to the intrabony defect. | Procedure or surgery | Entire Papila Preservation Tecnique |
Primary outcome
PROBİNG DEPTH
Time frame: 1 YEARS
Probing Depth (PD) refers to the distance from the gingival margin to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value
Clinical Attachment Level
Time frame: 1 YEARS
Clinical Attachment Level (CAL) is defined as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontal Bone Loss, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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: status not confirmed, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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?
PROBİNG DEPTH (time frame: 1 YEARS). 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?
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 20 Dec 2024.