A Closed Surgical Technique vs Papilla Preservation Techniques

NCT ID: NCT05754307

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2024-12-30

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

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Access Flap

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Closed Surgical Technique

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danae A. Apatzidou

OTHER

Sponsor Role: lead

Responsible Party

Danae A. Apatzidou

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Danae Apatzidou, Associate Professor

Role: STUDY_DIRECTOR

School of dentistry

Locations

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

Thessaloniki, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Danae Apatzidou, Associate Professor

Role: CONTACT

perioapatzidou@yahoo.gr

6934770361

Athanasios Tsolakis, PG student

Role: CONTACT

tantsisa@yahoo.gr

+306980593980

Facility Contacts

Danae Apatzidou, Assoc Professor

Role: primary

perioapatzidou@yahoo.gr

6934770361

Athanasios Tsolakis, PG student

Role: backup

tantsisa@yahoo.gr

+306980593980

References

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.

Reference Type: BACKGROUND

PMID: 29687448 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 7782979 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10815597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17243998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33899259 (View on PubMed)

Other Identifiers

AUTh 179/30-11-2022

Identifier Type: -

Identifier Source: org_study_id