Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial

Jose Antonio Moreno Rodríguez, Antonio José Ortiz Ruiz, Jose Antonio Moreno Rodríguez, Antonio José Ortiz Ruiz

Abstract

Objectives: This parallel, randomized controlled clinical trial evaluated the influence of bone substitutes (BS) on the efficacy of the non-incised papillae surgical approach (NIPSA) with enamel matrix derivate (EMD) in resolving deep, isolated, combined non-contained intrabony and supra-alveolar periodontal defects, preserving the soft tissue.

Material and methods: Twenty-four patients were randomized to treatment with NIPSA and EMD or NIPSA plus EMD and BS. Bleeding on probing (BoP), interproximal clinical attachment level (CAL), interproximal probing depth (PD), recession (REC), location of the tip of the papilla (TP), and width of the keratinized tissue (KT) were evaluated before surgery and at 1 year post-surgery (primary outcomes). Wound closure was assessed at 1 week post-surgery, and supra-alveolar attachment gain (SUPRA-AG) was recorded at 1 year post-surgery.

Results: At 1 week, 87.5% of cases registered complete wound closure and there were no cases of necrosis, without differences between groups (p > .05). At 1 year, all cases showed negative BoP. A significant PD reduction (NIPSA + EMD 8.25 ± 2.70 mm vs. NIPSA + EMD + BS 6.83 ± 0.81 mm) and CAL gain (NIPSA + EMD 8.33 ± 2.74 mm vs. NIPSA + EMD + BS 7.08 ± 2.68 mm) were observed (p < .001) in both groups, without significant between-group differences (p > .05). The residual PD was < 5 mm in all defects (NIPSA + EMD 2.50 ± 0.67 mm vs. NIPSA + EMD + BS 2.67 ± 0.78 mm). Soft tissues were preserved without significant between-group differences (REC: NIPSA + EMD 0.25 ± 0.45 mm vs. NIPSA + EMD + BS 0.17 ± 0.58 mm, p > .05; KT: 0.00 ± 0.43 mm vs. 0.08 ± 0.67 mm, p > .05). There were improvements in the papilla in both groups (TP: NIPSA + EMD 0.33 ± 0.49 mm vs. NIPSA + EMD + BS 0.45 ± 0.52 mm, p > .05), which was only significant in the NIPSA EMD + BS group (0.45 ± 0.52 mm; p < .05). In both groups, CAL gain was recorded in the supra-alveolar component, showing full resolution of the intrabony component of the defect in all cases (SUPRA-AG: NIPSA + EMD 1.83 ± 1.11 mm vs. NIPSA + EMD + BS 2.00 ± 1.76 mm, p > .05).

Conclusions: NIPSA and EMD with or without BS seem to be a valid surgical approach in the treatment of isolated, deep non-contained periodontal defects. In our study, both treatments resulted in significant PD reduction and CAL gain, that extended in the supra-alveolar component, without differences with the use of BS. Both treatments resulted in soft tissue preservation. However, the addition of BS may improve interdental papillary tissue.

Clinical relevance: NIPSA, with or without bone substitutes, resulted in significant periodontal improvement, with soft tissue preservation in isolated, deep non-contained periodontal defects. The application of bone substitutes may provide interproximal soft tissue gain.

Clinical trial registration: Clinicaltrials.gov: NCT04712630.

Keywords: Clinical trial; Microsurgery; Periodontal regeneration; Periodontitis.

Conflict of interest statement

The authors declare no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flow chart of the study
Fig. 2
Fig. 2
NIPSA EMD without BS. a Periapical diagnostic X-ray. b Interproximal PD before surgery. c Apical incision. d Elevation of tissue coronal to the incision to expose the bone peaks delimiting the defect and coronal traction of the interproximal tissue to expose the supra-alveolar component. Internal appearance of the periodontal pocket around the affected root surface. e Intrabony component of the defect after debridement of granulation tissue and removal of the periodontal pocket. Intrabony defect configuration: 3-wall component in deepest aspect and 1-wall in coronal aspect (non-contained defect). f Probe of the 3-wall component of the intrabony defect. g Suture and preservation of marginal tissue. h Primary wound closure at 1 week post-surgery. i–j One-year follow-up. Improvement in residual PD and interproximal soft tissue. Periapical X-ray shows complete bone filling (no standardized radiographs)
Fig. 3
Fig. 3
NIPSA + EMD + BS. a–b Interproximal PD and periapical X-ray before surgery. Deep combined non-contained intrabony and supra-alveolar periodontal defect. Soft tissue superficial fibrous tone after the pre-surgical procedures, and “red-wine” translucent from the deep aspect. c Apical incision in the mucosa located on the cortical bone tissue, as far as possible from the marginal tissues. d Elevation of the tissue coronal to the incision to expose the bone peaks delimiting the non-contained intrabony defect and coronal traction of the interproximal tissue to expose the supra-alveolar component. e–f Biomaterials application. g Suture. h Primary wound closure and soft tissue preservation 1 week post-surgery. i–j One-year follow-up. Soft tissue preservation and healthy aspect. Periapical X-ray (no standardized radiographs)

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