NCT06744348

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

December 2, 2024

Last Update Submit

December 19, 2024

Conditions

Keywords

microsurgeryclinical attachment level

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 YEARS

Study Arms (1)

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

Procedure: ENTİRE PAPİLLA PRESERVATİON

Interventions

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.

Entire Papila Preservation Tecnique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Konya Necmettin Erbakan Üniversitesi

Konya, Meram, 42090, Turkey (Türkiye)

Location

Konya Necmettin Erbakan Üniversitesi

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 20, 2024

Study Start

July 25, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

December 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations