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NCT Number: NCT06744348

Entire Papilla Preservation Technique in the Treatment of Periodontal IntraBony Defects: a 1-year Follow-up Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Necmettin Erbakan Üniversitesi, Konya, Meram, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENTİRE PAPİLLA PRESERVATİON

Procedure

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study 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

Acronym: EPP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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