Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06428149

Three Types of Papilla Incision in Periodontal Surgery

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

Location status: Recruiting

Location contact

JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS

CONTACT

+34 620538483

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Midline interproximal soft-tissue incision

Procedure

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 the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth.

Marginal approach by palatal incision

Procedure

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.

minimally invasive surgical technique

Procedure

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 teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine.

Primary outcomes

  1. Bleeding on probing

    Time frame: 12 months

    Bleeding on probing could be positive or negative

  2. Clinical attachment level (CAL)

    Time frame: 12 months

    Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket

  3. Probing pocket depth (PD)

    Time frame: 12 months

    Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket

  4. Recession (REC)

    Time frame: 12 months

    Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

  5. Location of the tip of the papillae (TP)

    Time frame: 12 months

    Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.

  6. Keratinized tissue width (KT)

    Time frame: 12 months

    Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.

Secondary outcomes

  1. Supra-alveolar attachment gain (SUPRA-AG)

    Time frame: 12 months

    Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.

Study contacts

Contact information is provided by the study sponsor or research team.

ANTONIO J ORTIZ-RUIZ, MD

CONTACT

[email protected]

+34 868888581

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2024
Registry last updated
Mar 28, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.