Comparison the effect of connective tissue grafting and collagen matrix with the tunnel method to cover the root surface of patients with Gingival recession
Comparison of the effect of connective tissue grafting and collagen matrix using the tunnel method on the Percentage of root coverage and dentine sensitivity
Design
In this parallel trial, the compared groups, including 20 participants in each group, have been assigned to the studied groups by the random block method.
Settings and conduct
In this study, the patients referred to periodontics department of Babol Dental School who referred for the treatment of multiple adjacent gingival recession were included in the trial based on the inclusion and exclusion criteria in the studied groups. All patients were provided with adequate information about the objectives of the study and written consent was obtained before entering the study. Surgeries were performed according to the instructions for the patients. Treatment results were evaluated according to relevant protocols. The patients were not aware of the allocation to the intervention groups so the study was conducted in a single blinded manner.
Participants/Inclusion and exclusion criteria
Patients referred to the periodontics department of Babol Dental School who have been referred for the treatment of gingivitis recession.
Intervention groups
Patients receiving transplanted tissue or connective tissue, which is a kind of main animal tissue, whose work is to protect and support other tissues.
Patients receiving matrix collagen used in intraoral surgeries as a restorative material for orbital floor fractures, in the treatment of local gingivitis, as a scaffold in tissue engineering to produce dental pulp, to cover small soft tissue defects in the oral cavity and Other cases can be used.
Main outcome variables
Percentage of root coverage and dentine sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059735N1
Registration date:2024-06-12, 1403/03/23
Registration timing:retrospective
Last update:2024-06-12, 1403/03/23
Update count:0
Registration date
2024-06-12, 1403/03/23
Registrant information
Name
mehrdad gholipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 6895
Email address
khodabandiali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2024-01-19, 1402/10/29
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2024-01-19, 1402/10/29
Trial completion date
2024-03-18, 1402/12/28
Scientific title
Comparison the effect of connective tissue grafting and collagen matrix with the tunnel method to cover the root surface of patients with Gingival recession
Public title
Investigating the effect of collagen matrix in the treatment of Gingival recession
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Patients with general health
Presence of one or more Miller class I bilateral Gingival recession in canine and premolar teeth (minimum 2 and maximum 3 teeth)
Having a minimum gingival recession of ≥3 mm
Visible Cemento‐enamel junction
The selected teeth should be without buccal filling and without bleeding after probing.
The ability to maintain proper dental hygiene
At least 1 mm of apical keratinized tissue
Has a cosmetic problem or dentine sensitivity
Exclusion criteria:
Pregnancy and breastfeeding
Smoking
Tooth with root decay
Cervical lesions or cervical restoration
Extruded, rotated and proclined teeth
History of surgery
Suffering from a systemic disease
Use of corticosteroids and anticancer drugs
Use of drugs affecting periodontal tissue
Known allergy to drugs used in surgery
Active infectious disease (hepatitis, tuberculosis and AIDS)
Use of movable prosthesis in the desired area
Use of movable prosthesis in the desired area
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The quadruple block method is used for randomization in this trial. How to randomize is with blocks of four with sequence AABB, ABAB, BABA, BBAA,. The randomization unit is individual. Randomization is done using Random Allocation software. Codes are assigned to the samples for concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants do not know the type of surgery used to treat their gingival recession (connective tissue graft or collagen matrix).
According to the type of treatment interventions that are specialized, the patients are not familiar with the type of intervention and only requested to cover the root surface of the tooth, and based on the ethical considerations of the study and the harmlessness of the used interventions, they received one of the treatments randomly. and the patients do not know the details of the interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol I, Ganj Afrooz Road, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.MUBABOL.REC.1401.024
Health conditions studied
1
Description of health condition studied
Gingival recession
ICD-10 code
K06.0
ICD-10 code description
Other disorders of gingiva and edentulous alveolar ridge
Primary outcomes
1
Description
Increase the percentage of root coverage
Timepoint
1, 3 and 6 months after surgery
Method of measurement
The percentage of root coverage will be calculated based on the following formula: the vertical depth of gingival rcession before surgery minus the vertical depth of gingival recession after surgery divided by the vertical depth of gingival recssion before surgery multiplied by 100
Secondary outcomes
1
Description
Decreased dentine sensitivity
Timepoint
1, 3 and 6 months after surgery
Method of measurement
Dentin sensitivity will be evaluated by the patient using the visual pain scale (VAS) after stimulating the buccal surface of the restored teeth for 1 second at a distance of about 1 cm by separating the cotton roll.
Intervention groups
1
Description
Intervention group: Patients receiving matrix collagen: Xenogenic collagen matrix has been proposed as a possible alternative to soft tissue grafting to increase KT band around teeth and implants during localized treatment and multiple gingival recession. It increases the stability and presence of internal factors of cell growth in the affected area, increases the rate of cell division of keratinocytes and fibroblasts, and accelerates the epithelialization process. According to the number of teeth that need gum grafting, different sizes of collagen matrix are used, such as: 20 x 15 mm, 20 x 30 mm, and 30 x 40 mm. The collagen matrix is first cut to the desired size by tissue scissors and then placed between the bone and gum tissue by means of apical sutures. In this study, the matrix of Hematrix factory prepared from animal collagen (DIO Pars company) is used.
Category
Treatment - Surgery
2
Description
Control group: Patients receiving transplanted tissue or connective tissue, which is a kind of main animal tissue, whose work is to protect and support other tissues. In this therapeutic intervention, the papilla and the margin of the gum are slowly separated from the bone in such a way that it does not tear. So that the desired tissue moves completely to the coronal direction or in fact all its fibers are separated from the bone and muscles. Then the connective tissue between The gum tissue and bone are placed by means of an instrument and the set is moved towards each other and towards the apical side by means of a suture. In this surgery, due to the lack of access to the special tunneling kit, first the necessary cuts are made in the gum sulcus and papilla area with a 15c blade. Then, in order to lift the gum from the bone, the periosteal elevator, periotome and sometimes the periodontal probe are used. 0-4 vicryl thread is used for the final suture. The desired connective tissue, which is taken from the roof of the patient's palate, is approximately one millimeter thick. Its dimensions are determined based on the number of teeth that need to be transplanted. To transplant a tooth, connective tissue measuring 10 x 10 mm is removed. For 2 teeth, 10 x 20 mm, and in the same way, its dimensions increase or decrease based on the number of teeth. The training sessions of this surgery were done on the model with the supervisor for one hour, and since they had already emphasized on this treatment method and the necessary training had been given, this one training session was enough.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, Babol School of Dentistry
Full name of responsible person
Mehrdad Qolipour
Street address
Babol - Velayat Square - Palestine St. - in front of Roz Bazaar - P853
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
khodabandiali@gmail.com
Web page address
https://dentistry.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Naqibi Sistani
Street address
Ganj Afrooz Street, Babol University of Medical Sciences, Vice President of Research and Technology
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3229 1408
Email
mnaghibis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?