Department of Periodontology, Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
Location status: Recruiting
Location contact
Nishi Tanwar, MDS
CONTACT
Sanjay Tewari, MDS
CONTACT
NCT Number: NCT06988839
The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. The main question it aims to answer is that :
Does the use of microneedling procedure followed by coronally advanced flap has similar outcomes of root coverage in recession type 1 (RT1) gingival recession i.e. buccal gingival recessions without interdental clinical attachment loss in thin gingival phenotype as compared to coronally advanced flaps with connective tissue graft.
Systemically healthy patients having isolated upper RT1 gingival recession will be assigned into two groups. Microneedling will be performed in one group (4 sessions each at a 10 days interval) followed by coronally advanced flap operation (at an interval of 2 months) and coronally advanced flap with connective tissue graft will be performed in the other group. Follow-up will be done at 1 month, 3 months and 6 months for evaluation of primary and secondary outcomes.
Interested in participating?
Request Info20 year–50 year
All sexes
Interventional
Not applicable
Rohtak, Haryana, 124001, India
Location status: Recruiting
Nishi Tanwar, MDS
CONTACT
Sanjay Tewari, MDS
CONTACT
The gingival phenotype affects the choice of mucogingival surgical technique for coverage of the root surface in gingival recession. It has been reported that a flap thickness of > 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of < 0.8 mm results in partial root coverage in coronally advanced flap procedure for Miller class I or II root coverage. Thus connective tissue graft (CTG) use is advocated in thin phenotype cases, for improved clinical and esthetic outcomes. Connective tissue graft increases the predictability of coronally advanced flap. Treatment by addition of connective tissue graft has some drawbacks like creation of a second surgical site, postoperative discomfort and long chair side time, leading the researchers to explore techniques less invasive in nature.
Microneedling (MN), also known as "percutaneous collagen induction therapy." It creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors, are released. In microneedling, the tissue responds as if experiencing minor trauma and the body's own collagen production is induced to preserve skin integrity. Microneedling as opposed to connective tissue grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the gingival thickness and keratinized tissue width of individuals with thin gingival phenotype. It is associated with higher patient acceptance, lesser surgical site co-morbidities and is a minimally invasive yet an effective approach to augment the gingiva. The histological analysis performed one year post microneedling sessions, showed increased collagen and elastic fiber accumulation in the reticular dermis, a thickened epidermis and a normal stratum corneum, showing its greater effect on gingival thickness.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by coronally advanced flap procedures in thin gingival phenotype. This technique is proposed to improve thin gingival phenotype by minimally invasive and non-surgical means.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling.
Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.
Time frame: Baseline,1,3,6 months
It will be recorded in mm with a periodontal probe from the CEJ to the crest of the gingival margin at the mid-labial region
Time frame: Baseline, 1 , 3 and 6 months
It will be recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
Time frame: Baseline ,1,3 and 6 months
It will be calculated according to formula Root coverage percentage= RD (preop -postop) *100 /RD preoperative
Time frame: Baseline, 6 months
The RES system evaluates 5 variables 6 months following surgery: gingival margin, marginal tissue contour (MTC), soft tissue texture (STT), Mucogingival junction alignment, and gingival color (GC). 0, 3, or 6 points will be used for the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables
Time frame: Baseline,1,3 and 6 months
Each patient will be questioned about his/her satisfaction with regard to following criteria: root coverage attained, dentinal hypersensitivity, shape and contour of gums, surgical procedure, and post-surgical phase and it will be assessed using a three-point rating scale.
Time frame: Baseline, 1 , 3 ,6 months
Clinical attachment level will be measured as the distance between the CEJ and the base of pocket. Measurements will be made at 6 sites of each tooth using periodontal probe.
Time frame: Baseline,1 ,3 and 6 months
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. Measurements will be noted at 6 sites of a tooth.
Time frame: Baseline, 1 ,3 and 6 months
Plaque index will be measured on buccal and lingual surface with Periodontal probe.
Time frame: Baseline,1,3 and 6 months
Gingival index will be used to assess severity of gingival inflammation with the help of periodontal probe at 4 sites.
Time frame: Baeline, 1 ,3 and 6 months
A No:15 endodontic spreader with silicon disc as stopper will be inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue will be felt. The depth of penetration will be noted using digital calliper measuring the distance between the tip of the spreader and silicon disc.
Contact information is provided by the study sponsor or research team.
Kashish, BDS
CONTACT
Nishi Tanwar, MDS
CONTACT
Postgraduate Institute of Dental Sciences Rohtak
Other
Patient-Centered And Clinical Outcomes Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype : A Randomized Controlled Clinical Trial
Acronym: RT1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04920136
Gingival Diseases, Gingival Recession
Birmingham, Alabama, United States
View Trial DetailsNCT07687654
Gingival Diseases, Gingival Recession
Adıyaman, Merkez, Turkey (Türkiye)
View Trial DetailsNCT05688293
Gingival Diseases, Gingival Recession
Cairo, Egypt
View Trial DetailsNCT05633511
Gingival Diseases, Gingival Recession
Boston, Massachusetts, United States
View Trial Details