Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peCTG+CAF
CTG+CAF
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972).
Exclusion Criteria:
- Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009).
Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CTG+CAF
peCTG+CAF
Arm Description
The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap
A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap
Outcomes
Primary Outcome Measures
Recession Depth in mm
The vertical amount of root exposed will be measured using a UNC-15 periodontal probe
Secondary Outcome Measures
Recession Width in mm
The width of the exposed root will be measured using a UNC-15 periodontal probe
Probing depth in mm
Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe
Gingival thickness in mm
the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia
Width of keratinized gingiva in mm
from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe
Root coverage esthetic score (Cairo et al. 2009)
evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score
Patient satisfaction (Kim et al. 2014)
measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03416673
Brief Title
Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession
Official Title
Clinical Effectiveness of Coronally Advanced Flap With Papillary Extended Connective Tissue Graft Versus Connective Tissue Graft in Miller Class III Recession: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2018 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
34 patients with Miller class III will be included in this study, where 17 participants will be treated with connective tissue graft with coronally advanced flap (control group) and 17 participants will be treated with a papillary extended connective tissue graft with coronally advanced flap (test group) and followed up for 6 months.
Detailed Description
Each patient will be inspected to check if the patient fits for the eligibility criteria. If the patient meets the standards, phase I therapy for periodontal plastic procedures will be performed including thorough supragingival scaling and subgingival debridement. Preservation of appropriate plaque control (both mechanical and chemical) by the patient will be executed as well.
Surgical procedures:
It will be done by the principal investigator.
CTG harvesting:
A measurement of the approximate length and width of the graft required will be taken. A CTG will be harvested from the palate using single incision technique as described by Kumar et al. (2013) as follows:
The graft will be harvested from the palate between the distal aspect of the canine and the mid-palatal region of the first molar.
A template will be placed on the palate to mark the extent of the graft, after local anesthesia is administered.
A single incision 2 mm apical to the gingival margin will be done. The blade will be placed approximately parallel to the long axis of the palate to provide the first incision.
The partial thickness flap will be raised as far apically as required, in accordance with the graft size, as measured by the template, using a periosteal elevator. The thickness of the flap will be sufficient to reduce the probability of tearing and sloughing.
Following this, the blade will be angled perpendicular to the palate through the same incision and continued to the bone. After the incision to the bone, the connective tissue will be elevated from the underlying bone with a periosteal elevator. Then two vertical incisions on the mesial and distal ends of the graft and one horizontal medial incision will be performed (under the partial thickness flap), to release it from the surrounding tissue.
The graft will be harvested through that single incision and pressure applied to the donor site with gauze soaked in saline after the graft was taken. The donor site will be sutured using a 4-0 silk suture.
For the peCTG, the CTG will be furtherly prepared by creating the papillary extensions using a tissue punch, according to the number of teeth with gingival recession.
Surgical protocol:
The surgical area will be prepared and adequately anesthetized using 4% articaine hydrochloride 1/100 000 epinephrine by giving block and/or infiltration anesthesia. After attaining adequate anesthesia, at a point apical to the papilla tip, vertical incisions will be made lateral to the area of recession extending into alveolar mucosa. The alveolar mucosa between the two vertical incisions will then be undermined by sharp dissection with undermining going into the vestibule while remaining parallel with the surface. Then, a sulcular incision will be used to reflect the coronal portion of the flap by sharp dissection close to the periostium until reaching the split thickness incision
previously made in alveolar mucosa. A gingivoplasty of each papilla adjacent to the recession will then be performed. This excision will not reduce the height of the papilla, but is designed to create a bleeding surface which will serve as a bed for the connective tissue graft (Allen and Miller, 1989).
A triangular flap will be elevated by a sharp dissection with no. 15c scalpel blade to raise a combined full-partial thickness flap to the level of the MGJ.
In the test group (group A), peCTG will be placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ, and the papillary extensions are inserted interdentally covering the de-epithelized papillae, while in the control group (group B), CTG will be also placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ. In both groups, all graft material will be sutured to the periosteum using 6-0 resorbable suture. Finally the flaps will be positioned coronally to the CEJ without tension using 6-0 polyglycolic acid suture material. Hemostasis will be achieved by applying gentle finger pressure for 4 minutes.
Post-surgical protocol:
Postoperative oral analgesics (Ibuprofen 600 mg t.d.s) will be prescribed to the patients for the first 3 days then whenever desirable. Systemic antibiotic will be prescribed (Amoxicillin 500mg t.d.s) for 5 days to prevent the infection postsurgical.
Patients will be instructed to rinse with 0.12% Chlorhexidine oral rinse twice daily for 2 weeks.
Participants will be instructed to avoid excessive muscle tractioning or trauma to the treated areas for the first 3 weeks and will be told not to brush teeth involved in the surgery.
After 10-14 days the sutures will be removed.
Three weeks post surgically the patients will be instructed to gently brush the operated area with a soft tooth brush using roll technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTG+CAF
Arm Type
Active Comparator
Arm Description
The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap
Arm Title
peCTG+CAF
Arm Type
Experimental
Arm Description
A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap
Intervention Type
Procedure
Intervention Name(s)
peCTG+CAF
Intervention Description
A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed
Intervention Type
Procedure
Intervention Name(s)
CTG+CAF
Intervention Description
A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap
Primary Outcome Measure Information:
Title
Recession Depth in mm
Description
The vertical amount of root exposed will be measured using a UNC-15 periodontal probe
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recession Width in mm
Description
The width of the exposed root will be measured using a UNC-15 periodontal probe
Time Frame
6 months
Title
Probing depth in mm
Description
Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe
Time Frame
6 months
Title
Gingival thickness in mm
Description
the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia
Time Frame
6 months
Title
Width of keratinized gingiva in mm
Description
from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe
Time Frame
6 months
Title
Root coverage esthetic score (Cairo et al. 2009)
Description
evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score
Time Frame
6 months
Title
Patient satisfaction (Kim et al. 2014)
Description
measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972).
Exclusion Criteria:
Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009).
Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manar T Elzanaty, Master
Phone
+201001775660
Email
manar.elzanaty@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Noha A Ghallab, Doctorate
Phone
+201005263365
Email
noha.ghallab@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manar T Elzanaty, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22639845
Citation
Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.
Results Reference
background
PubMed Identifier
25644302
Citation
Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
Results Reference
background
PubMed Identifier
24174767
Citation
Kumar A, Sood V, Masamatti SS, Triveni MG, Mehta DS, Khatri M, Agarwal V. Modified single incision technique to harvest subepithelial connective tissue graft. J Indian Soc Periodontol. 2013 Sep;17(5):676-80. doi: 10.4103/0972-124X.119294.
Results Reference
background
PubMed Identifier
19335093
Citation
Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
Results Reference
background
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Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession
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