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NCT Number: NCT03997552

NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration

Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.

Recruiting

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Periodontal Pocket Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients diagnosed with periodontitis.
  • plaque index and bleeding index of < 30%.
  • periodontal lesions with pocket probing depth > 5 mm.
  • intrabony defect > 3 mm.
  • intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion criteria

  • patients with systemic diseases that contraindicated treatment.
  • third molars.
  • teeth with incorrect endodontic or restorative treatment.

Treatment and study plan

Non-incised papillae surgical approach (NIPSA)

Procedure

Periodontal reconstructive surgery

Marginal approach by palatal incision

Procedure

Periodontal reconstructive surgery

Minimally invasive surgical technique (MIST)

Procedure

Periodontal reconstructive surgery

Primary outcomes

  1. 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

  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. 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.

  4. 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 mmm.

  5. 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.

  6. Bleeding on probing

    Time frame: 12 months

    Bleeding on probing could be positive or negative.

Study contacts

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

Antonio J Ortiz-Ruiz, MD

CONTACT

[email protected]

+34 868888581

Jose A Moreno-Rodriguez

CONTACT

[email protected]

+34 620538483

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2019
Registry last updated
Feb 17, 2026

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.

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