- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744348
Entire Papilla Preservation Technique in the Treatment of Periodontal IntraBony Defects: a 1-year Follow-up Study (EPP)
December 19, 2024 updated by: Fatma Uçan Yarkaç, Necmettin Erbakan University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Konya, Turkey, 42090
- Konya Necmettin Erbakan Üniversitesi
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Meram
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Konya, Meram, Turkey, 42090
- Konya Necmettin Erbakan Üniversitesi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
• 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%
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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1 YEARS
|
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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.
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1 YEARS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2024
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
December 2, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 19, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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