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

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ClinicalTrials.gov Identifier: NCT03997578
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio José Ortiz Ruiz, MD, Universidad de Murcia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontitis Periodontal Bone Loss Periodontal; Lesion Procedure: NIPSA (Non-incised papilla surgical approach) Procedure: NIPSA plus connective tissue graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2024

Arm Intervention/treatment
Active Comparator: NIPSA
Patients will be treated with only NIPSA technique.
Procedure: NIPSA (Non-incised papilla surgical approach)
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.

Experimental: NIPSA plus Connective tissue graft
Patients will be treated with NIPSA technique associated to a connective tissue graft.
Procedure: NIPSA plus connective tissue graft
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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997578


Contacts
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Contact: Antonio J Ortiz-Ruiz, MD +34868888581 ajortiz@um.es
Contact: Jose A Moreno-Rodriguez +34 620538483 joseantonio171087@hotmail.com

Locations
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Spain
Centro Odontologico Del Sureste Slp Recruiting
Murcia, Spain, 30007
Contact: Antonio J Ortiz-Ruiz, MD    +34 868888581    ajortiz@um.es   
Contact: Jose A Moreno-Rodriguez    +34 620538483    joseantonio171087@hotmail.com   
Sponsors and Collaborators
Universidad de Murcia

Publications of Results:
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Responsible Party: Antonio José Ortiz Ruiz, MD, Professor and researcher, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03997578     History of Changes
Other Study ID Numbers: CEI 1864/2018 - CBE 100/2018
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Alveolar Bone Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy