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Effectiveness of hyaluronic acid application in coronally advanced flap(CAF) technique in root coverage

Protocol summary

Study aim
Determining the effect of using hyaluronic acid (HA) gel with Coronally Advanced Flap (CAF) technique on root cover of patients referred to the School of Dentistry of Islamic Azad University of Medical Sciences
Design
According to the results of the study of Radhika Kumar et al. (34) for PPD variable using Advanced Repeated Measure ANOVA Power Analysis option of PASS 11 software, considering  0.05 and  = 0.2, the mean standard deviation of the effect on the two time variables The measurement was equal to 0.25 with 4 replications and the type of intervention was equal to 0.11 with 2 repetitions. The minimum sample size required for 13 pairs of samples (13 controls and 13 items) was calculated. The value was calculated.
Settings and conduct
This study is a split-mouth randomized double-blind clinical trial on patients with bilateral Miller's cl 1 gingival recession and referred to the Department of Periodontics, School of Dentistry, Tehran Azad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients over 18 years of age.Patients with O'LEARY Index (plaque control index) less than 20%. (58 Presence of at least two buccal gingival analyzes (depth of analysis ≥ 2mm) and no loss of interproximal joints (Miller class در) in the anterior regions of the maxilla and mandible (central, lateral, canine, first and second premolars) that have bilateral Cosmetic problems or dental allergies. The presence of CEJ is clear and recognizable.Has sufficient gingival thickness. (thick biotype)
Intervention groups
For the case group after performing CAF technique from Crossed linked-hyaluronic acid (Hyaluronic acid, Hyadent BG, Bioscience, Germany
Main outcome variables
Probe depth / Analysis depth / Analysis width / Keratinized gingival width / Mean root cover / Miselin Complete root cover Clinical adhesion surface

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211106052978N1
Registration date: 2021-12-02, 1400/09/11
Registration timing: registered_while_recruiting

Last update: 2021-12-02, 1400/09/11
Update count: 0
Registration date
2021-12-02, 1400/09/11
Registrant information
Name
Fatemeh Zolfaghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2279 5839
Email address
dr.fateme.zolfaghari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-18, 1400/08/27
Expected recruitment end date
2022-05-17, 1401/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of hyaluronic acid application in coronally advanced flap(CAF) technique in root coverage
Public title
Effectiveness of hyaluronic acid in coronally advanced flap(CAF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age. Patients with O'LEARY Index (plaque control index) less than 20%. Presence of at least two buccal gingival analyzes (depth of analysis ≥ 2mm) and no loss of interproximal joints (Miller class در) in the anterior regions of the maxilla and mandible (central, lateral, canine, first and second premolars) that have bilateral Cosmetic problems or dental allergies. The presence of CEJ is clear and recognizable. Has sufficient gingival thickness. (thick biotype) Minimum keratinized gingival width (at least 1 mm for shallow lesions and 2 mm for ≥ 5 mm lesions) Controls and cases patients in similar areas (type of jaw, type of tooth
Exclusion criteria:
Systemic disease pregnancy Active periodontal disease in the desired area. (Probe depth more than 4mm and BOP) Presence of veneer or restoration with edge on CEJ. History of periodontal surgery in the desired areas in the last 6 months. Smoking Long-term use of antibiotics in the last 6 months. Use of steroids and drugs affecting periodontal tissues
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 13
More than 1 sample in each individual
Number of samples in each individual: 2
Presence of at least two buccal gingival analyzes (depth of analysis ≥ 2mm) and no loss of interproximal joints (Miller class در) in the anterior regions of the maxilla and mandible (central, lateral, canine, first and second premolars) that have bilateral Cosmetic problems or dental allergies.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, during surgery, using the coin toss method, it is determined which side of the case group and which side of the control group. In this way, the side of the control heads and the side of the case tails were considered, and after dropping the coin on the case side of hyaluronic acid gel, and on the control side, surgery without hyaluronic acid gel was performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, an examiner who measures clinical parameters and reviews and interprets the results, and participants are unaware of which side is the control and which side is the case. Participants (patients) did not know which side of the surgical site used the hyaluronic acid gel.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry, Tehran Azad University of Medical Sciences
Street address
9th neyestan pasdaran
City
tehran
Province
Tehran
Postal code
19585175
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.045

Health conditions studied

1

Description of health condition studied
gingival recession
ICD-10 code
K06.0
ICD-10 code description
Gingival recession

Primary outcomes

1

Description
Probe depth
Timepoint
base line / 6 weeks later / 3 months later / 6 months later
Method of measurement
Probing Pocket Depth (PPD): Measured in the midfacial area from the gingival margin to the end of the pocket by a periodontal probe.

2

Description
recession depth
Timepoint
base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later
Method of measurement
Recession Depth (RD): In the midfacial area from the CEJ to the most apical margin of the gingival margin

3

Description
recession width
Timepoint
base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later
Method of measurement
Recession Width (RW): The width of the gingival resorption is measured at the CEJ.

4

Description
width of keratinized tissue
Timepoint
base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later
Method of measurement
. The width of keratinized tissue, measured from the gingival margin to the MGJ, is measured in the medial region.

5

Description
Mean root coverage
Timepoint
base line / 6 weeks later / 3 months later / 6 months later
Method of measurement
Mean Root Coverage (MRC): The average percentage of root surface previously It was exposed but is now covered. Based on this formula, it is calculated: (Depth of initial analysis  RDi and depth of analysis day  RDp () (RDi-RDp) / RDi × 100

6

Description
Complete root coverage
Timepoint
base line / 6 weeks later / 3 months later / 6 months later
Method of measurement
Complete Root Coverage (CRC): Percentage of patients whose root surface is completely covered. And is calculated based on this formula: (number of specimens that received full root cover  NCRC and total number of specimens  NT) NCRC / NT × 100

7

Description
Clinical attachment level
Timepoint
base line / 6 weeks later / 3 months later / 6 months later
Method of measurement
Clinical Attachment Level (CAL): In the midfacial areas of RD + PPD

Secondary outcomes

empty

Intervention groups

1

Description
For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and after determining which side of the case and which side is the control; Crossed linked-hyaluronic acid (Hyaluronic acid, Hyadent BG, Bioscience, Germany) was used for the case group after CAF technique to cover the root surface before suturing. HA as a cartridge It is disposable and is inserted into the syringe, completely covering the root surface according to the factory instructions, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial.
Category
Treatment - Surgery

2

Description
Control group: For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry of Islamic Azad University of Tehran
Full name of responsible person
Fatemeh Zolfaghari
Street address
9th Neyestan Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 5796 8828
Email
Dr.fateme.zolfaghari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
9th Neyestan Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 5796 8828
Email
Dr.fateme.zolfaghari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Saeed Sadatmansouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neyestan Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 5796 8828
Email
drsaeed_sadatmansouri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Zolfaghari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
9th Neyestan Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 5766 8828
Email
Dr.fateme.zolfaghari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Saeed Sadatmansouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neyestan Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 5766 8828
Email
Drsaeed_sadatmansouri@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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