Health TrialsbyHealthPanel

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

ConditionsPeriodontitisPeriodontal Bone LossPeriodontal; Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Murcia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients diagnosed with periodontitis.

plaque index and bleeding index of < 30%.

periodontal lesions with pocket probing depth > 5 mm.

intrabony defect > 3 mm.

Disqualifiers

patients with systemic diseases that contraindicated treatment.

third molars.

teeth with incorrect endodontic or restorative treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NIPSA (Non-incised papilla surgical approach)

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NIPSAActive comparator 1 intervention
Group B: NIPSA plus Connective tissue graftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Probing pocket depth (PD)

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

Time frame
12 months
2

Clinical attachment level (CAL)

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

Time frame
12 months
3

Recession (REC)

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

Time frame
12 months
4

Location of the tip of the papillae (TP)

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Murcia

Lead sponsor

Source ClinicalTrials.gov
Apply now