Periodontal Attachment Loss, Periodontal Diseases, Periodontal Pocket, Periodontitis
Conditions
Brief summary
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.
Interventions
PROCEDURENon-incised papila surgical approach without grafting biomaterial
Periodontal reconstructive surgery
PROCEDURENon-incised papila surgical approach with grafting biomaterial
Periodontal reconstructive surgery
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth (PD) | 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 |
| Clinical attachment level (CAL) | 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. |
| Recession (REC) | 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. |
| Location of the tip of the papillae (TP) | 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. |
| Keratinized tissue width (KT) | 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. |
| Bleeding on probing | 12 months | Bleeding on probing could be positive or negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supra-alveolar attachment gain (SUPRA-AG) | 12 months | Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result. |
| Wound closure (WC) | 1 week | Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0). |
Countries
Spain
Outcome results
None listed