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A Closed Surgical Technique vs Papilla Preservation Techniques (CST)

Primary Purpose

Treatment of Residual Periodontal Pockets

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Access Flap
Closed Surgical Technique
Sponsored by
Danae A. Apatzidou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Residual Periodontal Pockets focused on measuring interdental periodontal defect, periodontal surgery, papilla preservation, tunnelling technique, closed surgical technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Probing Pocket Depth
Determined by a manual periodontal probe
Recession
Determined by a manual periodontal probe
Reduction of proinflammatory cytokines
Determined by ELISA in GCF
Bleeding on Probing
Determined by a manual periodontal probe
Patient satisfaction and perception
Determined on questionnaires

Full Information

First Posted
February 22, 2023
Last Updated
February 22, 2023
Sponsor
Danae A. Apatzidou
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1. Study Identification

Unique Protocol Identification Number
NCT05754307
Brief Title
A Closed Surgical Technique vs Papilla Preservation Techniques
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Danae A. Apatzidou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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 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 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 Fourth visit - T2 (6 weeks post-operatively) Oral hygiene instructions Intra-oral photography 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Residual Periodontal Pockets
Keywords
interdental periodontal defect, periodontal surgery, papilla preservation, tunnelling technique, closed surgical technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled clinical trial having 2 parallel intervention arms for surgical treatment (step 3) of interproximal residual defects (PPD≥6mm and BoP)
Masking
ParticipantOutcomes Assessor
Masking Description
Treatment is disclosed to the examiner after all data have been collected.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Access Flap
Intervention Description
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
Intervention Name(s)
Closed Surgical Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Determined by a manual periodontal probe(Hu-Friedy XP-23/QW) by a single examiner at the nearest of 1mm
Time Frame
baseline to 6 months
Title
Cementoenamel junction to Bottom of the defect
Description
Determined on standardised periapical radiographs obtained by the long cone parallel technique
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Probing Pocket Depth
Description
Determined by a manual periodontal probe
Time Frame
baseline to 6 months
Title
Recession
Description
Determined by a manual periodontal probe
Time Frame
baseline to 6 months
Title
Reduction of proinflammatory cytokines
Description
Determined by ELISA in GCF
Time Frame
baseline to 6 months
Title
Bleeding on Probing
Description
Determined by a manual periodontal probe
Time Frame
baseline to 6 months
Title
Patient satisfaction and perception
Description
Determined on questionnaires
Time Frame
2 weeks following surery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danae Apatzidou, Associate Professor
Phone
6934770361
Email
perioapatzidou@yahoo.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Tsolakis, PG student
Phone
+306980593980
Email
tantsisa@yahoo.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danae Apatzidou, Associate Professor
Organizational Affiliation
School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology
City
Thessaloniki
ZIP/Postal Code
54124
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danae Apatzidou, Assoc Professor
Phone
6934770361
Email
perioapatzidou@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Athanasios Tsolakis, PG student
Phone
+306980593980
Email
tantsisa@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Athanasios Tsolakis, PG student

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Overall data but not on an individual basis will be disclosed and shared
Citations:
PubMed Identifier
29687448
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
7782979
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.
Results Reference
background
PubMed Identifier
10815597
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.
Results Reference
background
PubMed Identifier
17243998
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.
Results Reference
background
PubMed Identifier
33899259
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.
Results Reference
background

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A Closed Surgical Technique vs Papilla Preservation Techniques

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