Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
Primary Purpose
Periodontal Pocket, Periodontal Diseases, Periodontal Bone Loss
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
periodontal surgery
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Pocket
Eligibility Criteria
Inclusion Criteria:
- Stage III or IV periodontitis, including all grades.
- Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
- Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
- Adherence to periodontal maintenance appointments.
Exclusion Criteria:
- Systemic disease contraindicating periodontal surgery.
- Teeth with incorrect endodontic treatment or restoration.
- Stage I or II periodontitis.
Sites / Locations
- Centro Odontologico Del Sureste SlpRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Test
Arm Description
Access flap periodontal surgery
Access flap periodontal surgery and periodontal granulation tissue debridement.
Outcomes
Primary Outcome Measures
Clinical attachment gain (CAG)
Clinical attachment gain
Secondary Outcome Measures
rPD
residual probing depth
PPDr
Probing pocket depth reduction
iGR
interproximal gingival recession
Early Healing Index (EHI)
Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively.
SUPRA-AG
Supra-alveolar attachment gain
Full Information
NCT ID
NCT05533528
First Posted
September 5, 2022
Last Updated
November 9, 2022
Sponsor
Universidad de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT05533528
Brief Title
Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
Official Title
Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.
The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).
Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Periodontal Diseases, Periodontal Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Access flap periodontal surgery
Arm Title
Test
Arm Type
Experimental
Arm Description
Access flap periodontal surgery and periodontal granulation tissue debridement.
Intervention Type
Procedure
Intervention Name(s)
periodontal surgery
Intervention Description
A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.
Primary Outcome Measure Information:
Title
Clinical attachment gain (CAG)
Description
Clinical attachment gain
Time Frame
12 months
Secondary Outcome Measure Information:
Title
rPD
Description
residual probing depth
Time Frame
12 months
Title
PPDr
Description
Probing pocket depth reduction
Time Frame
12 months
Title
iGR
Description
interproximal gingival recession
Time Frame
12 months
Title
Early Healing Index (EHI)
Description
Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively.
Time Frame
1 week
Title
SUPRA-AG
Description
Supra-alveolar attachment gain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III or IV periodontitis, including all grades.
Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
Adherence to periodontal maintenance appointments.
Exclusion Criteria:
Systemic disease contraindicating periodontal surgery.
Teeth with incorrect endodontic treatment or restoration.
Stage I or II periodontitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name or Official Title & Degree
José A Moreno-Rodríguez, DDS
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
Facility Information:
Facility Name
Centro Odontologico Del Sureste Slp
City
Murcia
ZIP/Postal Code
30007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name & Degree
Jose A Moreno-Rodriguez
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://doi.org/10.5051/jpis.2105780289
Description
A pilot prospective study on the periodontal granulation tissue preservation in surgical periodontal disease treatment
Learn more about this trial
Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
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