Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions (PRP)
Primary Purpose
Gingival Recession, Generalized
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAF+ADM+PRP
CAF+ADM
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
- must be able to have 2 mm-high keratinized tissue apical to the root exposures;
- must be able to have no systemic diseases that could influence the outcome of the therapy;
- must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
- must be non-smoker;
- must be not pregnant.
Exclusion Criteria:
- debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
- known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
- taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
- restorations or caries at the recession site;
- failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
- a previous periodontal surgery at the recession site and failure to complete the informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAF+ADM+PRP
CAF+ADM
Arm Description
Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)
Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP
Outcomes
Primary Outcome Measures
Root coverage (RC)
The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
Secondary Outcome Measures
Gingival recession depth (GRD)
The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
recession width (GRW)
Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
width of keratinized tissue (WKT)
Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
plaque index(PI)
plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
gingival index
gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
probing depth
PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.
Full Information
NCT ID
NCT03043638
First Posted
February 2, 2017
Last Updated
February 6, 2017
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Collaborators
Gazi University
1. Study Identification
Unique Protocol Identification Number
NCT03043638
Brief Title
Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions
Acronym
PRP
Official Title
Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2008 (Actual)
Primary Completion Date
June 20, 2011 (Actual)
Study Completion Date
June 20, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Collaborators
Gazi University
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
The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs).
12 patients with 84 Miller Class I or II recession defects were participated. Sites were randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD), recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively. The data were analyzed statistically.
Detailed Description
Several methods have been demonstrated for the treatment of gingival recession defects with the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no significant difference between PRP and CTG treated groups in terms of root coverage of Miller Class 1 or II buccal recession defects. However, in the same study contour and texture of soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al. compared coronally positioned tunnel technique and ADM application with and without PRP for the treatment of single gingival recession defects and reported no statistically significant root coverage difference between groups.
Although there are numerous root coverage procedures to treat the conditions, predictable coverage of multiple adjacent gingival recessions still remains a challenge for the clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus ADM application together with and without PRP to determine whether the PRP provided an advantage in terms of gaining coverage of deep and wide recession defects in the treatment of MAGRs.
In the present study, using a controlled blinded split-mouth design, 14 patients with multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control groups respectively. Two patients who failed to return for all postoperative visits were exited from the study.
Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm deep on non-molar teeth in the same dental arch at least two bilateral site, underwent through root coverage surgery and were followed for 12 months. The study sample consisted of 84 teeth associated with total of 12 patients; seven patients each showing a pair of three teeth, four patients each showing a pair of four teeth, and one patient showing a pair of five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD), clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing trauma to the gingival margin. Pre-surgical therapy included scaling, root planning, polishing and general oral hygiene instruction. All surgical procedures were performed with Coronally Advanced Flap technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized
Keywords
multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF+ADM+PRP
Arm Type
Experimental
Arm Description
Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)
Arm Title
CAF+ADM
Arm Type
Active Comparator
Arm Description
Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP
Intervention Type
Procedure
Intervention Name(s)
CAF+ADM+PRP
Intervention Description
CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.
Intervention Type
Procedure
Intervention Name(s)
CAF+ADM
Intervention Description
CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application
Primary Outcome Measure Information:
Title
Root coverage (RC)
Description
The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
Time Frame
The change in RC at 3rd month to 12th month
Secondary Outcome Measure Information:
Title
Gingival recession depth (GRD)
Description
The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
Title
recession width (GRW)
Description
Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
Title
width of keratinized tissue (WKT)
Description
Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
Title
plaque index(PI)
Description
plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
Title
gingival index
Description
gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
Title
probing depth
Description
PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.
Time Frame
Baseline, 3,6 and 12 months after periodontal surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
must be able to have 2 mm-high keratinized tissue apical to the root exposures;
must be able to have no systemic diseases that could influence the outcome of the therapy;
must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
must be non-smoker;
must be not pregnant.
Exclusion Criteria:
debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
restorations or caries at the recession site;
failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
a previous periodontal surgery at the recession site and failure to complete the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pelin Gokalp
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When needed data can be shared via email.
Citations:
PubMed Identifier
19254123
Citation
Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.
Results Reference
background
PubMed Identifier
30895121
Citation
Cetiner D, Gokalp Kalabay P, Ozdemir B, Cankaya ZT. Efficiency of platelet-rich plasma on acellular dermal matrix application with coronally advanced flap in the treatment of multiple adjacent gingival recessions: A randomized controlled clinical trial. J Dent Sci. 2018 Sep;13(3):198-206. doi: 10.1016/j.jds.2017.11.002. Epub 2018 Feb 3.
Results Reference
derived
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Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions
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