A Closed Surgical Technique vs Papilla Preservation Techniques

Periodontitis Clinical Trial

— CST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754307
• Other study ID #: AUTh 179/30-11-2022
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Aristotle University Of Thessaloniki
• Contact: Danae Apatzidou, Associate Professor
• Phone: 6934770361
• Email: perioapatzidou[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 30, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Danae A. Apatzidou

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View 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. — View 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

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cementoenamel junction to Bottom of the defect	Determined on standardised periapical radiographs obtained by the long cone parallel technique	baseline to 6 months
Secondary	Probing Pocket Depth	Determined by a manual periodontal probe	baseline to 6 months
Secondary	Recession	Determined by a manual periodontal probe	baseline to 6 months
Secondary	Levels of proinflammatory cytokines	Determined by ELISA in GCF	baseline to 6 months
Secondary	Bleeding on Probing	Determined by a manual periodontal probe	baseline to 6 months
Secondary	Patient satisfaction and perception	Determined on questionnaires	2 weeks following surery