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NCT Number: NCT03997578

Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.

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Key information

Conditions

Periodontitis Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Periodontal; Lesion 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

NIPSA (Non-incised papilla surgical approach)

Procedure

To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the regenerative biomaterials will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.

NIPSA plus connective tissue graft

Procedure

In these patients, the following methodology will be added to the technique described for the NIPSA group: once the biomaterials are applied, a connective tissue graft, taken at the level of the first upper molar, will be sutured to the base of the soft supra-alveolar tissue and to the palatal tissue, which has not been disinserted, using simple sutures.

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]

+34868888581

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) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: A Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2019
Registry last updated
Feb 19, 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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