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Recruiting NCT06428149

Three Types of Papilla Incision in Periodontal Surgery

No phase Interventional Periodontitis Periodontal Diseases Periodontal Pocket

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midline interproximal soft-tissue incision, Marginal approach by palatal incision, Minimally invasive surgical technique.
Who it may be relevant to
Registry conditions: Periodontitis, Periodontal Diseases, Periodontal Pocket. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. a Randomized Clinical Trial

Overview

Three types of papilla incision in periodontal reconstruction techniques will be compared.

Interventions

  • Procedure Midline interproximal soft-tissue incision
    Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of t
  • Procedure Marginal approach by palatal incision
    First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed.
  • Procedure Minimally invasive surgical technique
    The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the tee

Primary outcome measures

  • Bleeding on probing [Time frame: 12 months]
  • Clinical attachment level (CAL) [Time frame: 12 months]
  • Probing pocket depth (PD) [Time frame: 12 months]
  • Recession (REC) [Time frame: 12 months]
  • Location of the tip of the papillae (TP) [Time frame: 12 months]
  • Keratinized tissue width (KT) [Time frame: 12 months]
Secondary outcome measures (1)
  • Supra-alveolar attachment gain (SUPRA-AG) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with periodontal disease.
  • Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
  • Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
  • Plaque index and bleeding index less than 30%.

Exclusion criteria

  • Systemic disease that contraindicates periodontal surgery.
  • Pregnant women.
  • Third molars or teeth with incorrect endodontic or restorative treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Centro Odontologico Del Sureste Slp — Murcia

Identifiers

NCT: NCT06428149 · 2937/2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗