A Closed Surgical Technique vs Papilla Preservation Techniques (CST)

A "Closed" Surgical Technique for the Treatment of Residual Periodontal Pockets vs Access Flap Utilizing Papilla Preservation Techniques. A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Access Flap; Procedure: Closed Surgical Technique

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

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danae Apatzidou, Associate Professor; Phone Number: 6934770361; Email: perioapatzidou@yahoo.gr
• Study Contact Backup: Name: Athanasios Tsolakis, PG student; Phone Number: +306980593980; Email: tantsisa@yahoo.gr

Study Locations

• Greece
  • Thessaloniki, Greece, 54124
    • Recruiting
    • Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology
    • Contact: Athanasios Tsolakis, PG student; Phone Number: +306980593980; Email: tantsisa@yahoo.gr
    • Contact: Danae Apatzidou, Assoc Professor; Phone Number: 6934770361; Email: perioapatzidou@yahoo.gr
    • Principal Investigator: Athanasios Tsolakis, PG student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control surgical technique; Intrasulcular incisions at the teeth adjacent to the defect, using the simplified papilla preservation technique (SPPT) or modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.	Procedure: Access Flap; Intrasulcular incisions at the teeth adjacent to the defect, using the simplified papilla preservation technique (SPPT) or modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.
Experimental: Test surgical technique; Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentional excising the granulation tissue that lines the osseous defect. Flaps are repositioned by gentle pressure and suturing is not required.	Procedure: Closed Surgical Technique; Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentionally excising the granulation tissue that lines the osseous defect. Flaps are repositioned by gentle pressure and suturing is not required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level	Determined by a manual periodontal probe(Hu-Friedy XP-23/QW) by a single examiner at the nearest of 1mm	baseline to 6 months
Cementoenamel junction to Bottom of the defect	Determined on standardised periapical radiographs obtained by the long cone parallel technique	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth	Determined by a manual periodontal probe	baseline to 6 months
Recession	Determined by a manual periodontal probe	baseline to 6 months
Bleeding on Probing	Determined by a manual periodontal probe	baseline to 6 months
Patient satisfaction and perception	Determined on questionnaires	2 weeks following surery
Levels of proinflammatory cytokines	Determined by ELISA in GCF	baseline to 6 months

Collaborators and Investigators

• Sponsor: Danae A. Apatzidou
• Investigators: Study Director: Danae Apatzidou, Associate Professor, School of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: periodontal surgery; papilla preservation; interdental periodontal defect; tunnelling technique; closed surgical technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: AUTh 179/30-11-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Overall data but not on an individual basis will be disclosed and shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No