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Completed

NCT Number: NCT04712630

Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Pocket Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

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 papila surgical approach without grafting biomaterial

Procedure

Periodontal reconstructive surgery

Non-incised papila surgical approach with grafting biomaterial

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 mm.

  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.

Secondary outcomes

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

    Time frame: 12 months

    Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.

  2. Wound closure (WC)

    Time frame: 1 week

    Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial

Acronym: NIPSAGRAFT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

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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