Clinical trial NCT05754307: A Closed Surgical Technique vs Papilla Preservation Techniques
Official title: A "Closed" Surgical Technique for the Treatment of Residual Periodontal Pockets vs Access Flap Utilizing Papilla Preservation Techniques. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: interdental periodontal defect
periodontal surgery
papilla preservation
tunnelling technique
closed surgical technique
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled clinical trial having 2 parallel intervention arms for surgical treatment (step 3) of interproximal residual defects (PPD≥6mm and BoP)
Primary purpose: TREATMENT

Brief summary: A pioneer periodontal surgical approach employing the closed surgical technique (CST) has been designed to gain access to isolated interdental periodontal defects and retain the soft-tissue architecture. This technique is based on a modified tunnelling technique to retract full-thickness gingival flaps from the osseous defect in a closed manner retaining intact the interproximal papilla thus, suturing is not required. A randomised controlled clinical trial will determine the efficacy of the CST versus the access flap employing papilla preservation techniques over a period of 6 months.

Detailed description: This randomised controlled clinical trial will compare the CST over the access flap employing papilla preservation techniques to treat isolated interdental defects in terms of gain in clinical attachment levels, radiographic evidence of bone apposition and local reduction of pro-inflammatory cytokines over a period of 6 months.

1. First visit - initial examination - at least 3 months after initial non-surgical periodontal treatment (Step 1, 2) Update general and dental history Screening of subjects for suitability; Consent form; Randomization of suitable subjects Intra-oral photography Full-mouth charting: Probing pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (Rec) Oral hygiene instructions (soft toothbrush, modified Bass, interdental cleaning) Full mouth supragingival scaling
2. Second visit - Baseline - T0 Collection of Gingival Crevice Fluid (GCF) using sterilized paper strips Radiographic examination of the site (Long-cone paralleling technique using a digital sensor attached to a custom-made silicone bite block for reproducible radiographs) Periodontal site-selected clinical assessment Periodontal surgery (control: access flap with papilla preservation techniques or test: the CST) under local anaesthesia Modification of oral hygiene instructions; post-operative instructions Intra-oral photography
3. Third visit - T1 (2 weeks post-operatively) Suture removal (only in control group) Wound healing visual monitoring by the Early Healing Index (1-5) Oral hygiene instructions Intra-oral photography Questionnaire for subjective feelings and satisfaction
4. Fourth visit - T2 (6 weeks post-operatively) Oral hygiene instructions Intra-oral photography
5. Fifth visit - T3 - Re-evaluation (6 months post-operatively) GCF collection using sterilized paper strips Periodontal full-mouth charting Site-selected periodontal clinical assessment; Probing Pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (Rec Radiographic examination of the site Oral hygiene instructions Intra-oral photography

Eligibility criteria: Inclusion Criteria:

* Systematically healthy subjects, not having consumed antibiotics 3 months before surgical periodontal treatment (baseline)
* Smokers \<5 cig/day, former smokers or no smokers
* Periodontal patients fulfilling non surgical initial periodontal treatment at least 3 months before surgical periodontal treatment (baseline day) and presenting at least one residual pocket with PPD and CAL ≥6mm and bleeding on probing, located interproximally with intrerdental site ≥2mm.
* Compliant patients presenting high standards of oral hygiene (full mouth Plaque Index \<20%) strictly susceptible in Supportive Periodontal Treatment

Exclusion Criteria:

* Untreated active periodontal inflammation
* Poorly controlled systematic diseases
* Disorders compromise wound healing
* Bisphosphonate medications
* Patients under radiotherapy or chemotherapy
* Drug-indused gingival hyperplasia
* Pregnancy or lactation
* Poor compliance during steps 1 and 2 of cause-related periodontal treatment
* Compromised oral hygiene (full mouth Plaque Index \>30%), circumferential bone defect or narrow intrerdental site ≤2mm.

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: baseline to 6 months
measure: Cementoenamel junction to Bottom of the defect
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Probing Pocket Depth
timeFrame: baseline to 6 months
measure: Recession
timeFrame: baseline to 6 months
measure: Levels of proinflammatory cytokines
timeFrame: baseline to 6 months
measure: Bleeding on Probing
timeFrame: baseline to 6 months
measure: Patient satisfaction and perception
timeFrame: 2 weeks following surery
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology
Study officials:
affiliation: School of Dentistry
name: Danae Apatzidou, Associate Professor
role: STUDY_DIRECTOR
References:
citation: Apatzidou DA, Nile C, Bakopoulou A, Konstantinidis A, Lappin DF. Stem cell-like populations and immunoregulatory molecules in periodontal granulation tissue. J Periodontal Res. 2018 Aug;53(4):610-621. doi: 10.1111/jre.12551. Epub 2018 Apr 23.
citation: Apatzidou DA. A pionner surgical technique for isolated periodontal defects by "closed" retraction of the papilla' Front. Dent. Med. (2022) 3:956601. doiQ 10.3389
citation: Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
citation: Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999 Dec;19(6):589-99.
citation: Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. doi: 10.1111/j.1600-051X.2006.01020.x.
citation: Apatzidou DA, Bakopoulou AA, Kouzi-Koliakou K, Karagiannis V, Konstantinidis A. A tissue-engineered biocomplex for periodontal reconstruction. A proof-of-principle randomized clinical study. J Clin Periodontol. 2021 Aug;48(8):1111-1125. doi: 10.1111/jcpe.13474. Epub 2021 May 14.