A Closed Surgical Technique vs Papilla Preservation Techniques

NCT05754307 | Recruiting

• 1 other identifier: AUTh 179/30-11-2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

interdental periodontal defect; periodontal surgery; papilla preservation; tunnelling technique; closed surgical technique

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Probing Pocket Depth

  baseline to 6 months

• Recession

  baseline to 6 months

• Levels of proinflammatory cytokines

  baseline to 6 months

• Bleeding on Probing

  baseline to 6 months

• Patient satisfaction and perception

  2 weeks following surery

Study Arms (2)

Control surgical technique

ACTIVE COMPARATOR

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

Test surgical technique

EXPERIMENTAL

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

Interventions

Access Flap PROCEDURE

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.

Control surgical technique

Closed Surgical Technique PROCEDURE

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.

Test surgical technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danae A. Apatzidou: lead

Study Sites (1)

Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (6)

• 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.

  PMID: 29687448 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 7782979 BACKGROUND

• 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.

  PMID: 10815597 BACKGROUND

• 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.

  PMID: 17243998 BACKGROUND

• 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.

  PMID: 33899259 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Danae Apatzidou, Associate Professor

  School of dentistry

  STUDY DIRECTOR

Central Study Contacts

Danae Apatzidou, Associate Professor

CONTACT

6934770361; perioapatzidou@yahoo.gr

Athanasios Tsolakis, PG student

CONTACT

+306980593980; tantsisa@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Treatment is disclosed to the examiner after all data have been collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised controlled clinical trial having 2 parallel intervention arms for surgical treatment (step 3) of interproximal residual defects (PPD≥6mm and BoP)

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: March 3, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)