Comparing two techniques using blood derived product for treatment of thin gum tissues in healthy individuals.

Phase 2/3

Completed

Conditions: Illness, unspecified,

Registration Number: CTRI/2022/05/042683

Lead Sponsor: DR B NAMRATHA SAI

Brief Summary: AIM: The aim of this present study is to compare and evaluate the therapeutic effect of injectable platelet rich fibrin alone and injectable platelet rich fibrin in combination with microneedling on the thickness and width of keratinized gingiva in individuals with thin gingival phenotypes.

All the participants will be explained about the aim, nature, and design of the study along with a written informed consent for their participation before the commencement of the study.

The study is planned as a randomized clinical trial conducted in healthy individuals with thin gingival phenotype . The study duration is 6 months in which the clinical parameters will be recorded at baseline, 1, 3 and 6 months.

The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013.

The clinical parameters for assessment include:

1)Gingival thickness

2)Keratinized tissue width

3)Clinical attachment level

4)Probing depth

5)Plaque index

6)Gingival index

7)Modified sulcular bleeding index.

All patients included in the study will be evaluated before the treatment procedure and patients with thin gingival phenotype in the mandibular anterior teeth and premolars are selected.

Two sites left and right halves of the mandibular arch will be selected and assigned as test and control group.

Test group: gingival augmentation with microneedling and injectable platelet rich fibrin.

control group: gingival augmentation with injectable platelet platelet rich fibrin.

Procedure: The thickness of the gingiva will be measured using No:15 endodontic spreader. The spreader will be inserted perpendicularly at 1.5 mm apical to the gingival margin in the mid-buccal region through the soft tissues until a hard surface was felt. The silicon disk(stopper) will be laid in tight contact with the soft tissue surface and will be attached with a drop of cyano-acrylic adhesive. The penetration depth between the silicone disc and the spreader tip will be measured using digital vernier calliper.

PREPARATION OF INJECTABLE PLATELET RICH FIBRIN: Before all procedures, a venous blood sample will be collected once for each patient using a 20-ml syringe and will be separated into two i-PRF tubes of 10 ml each containing no anticoagulant and will be centrifuged at room temperature for 8 minutes at 600 rpm (44g force).The injectable platelet rich fibrin obtained will be placed in 2.5 cc dental injectors. The 27-gauge dental injector needles will be used for injection of injectable platelet rich fibrin.

MICRONEEDLING: Thirty-gauge (0.255 mm) lancet needles will be vertically inserted into the tissue until the hard tissue is reached. Microneedling will be carried out on keratinized gingiva from the mesial line angle to the distal line angle of the tooth to be treated with the help of a lancet.

ADMINISTRATION PROTOCOL: A total of 4 sessions of microneedling and injectable platelet rich fibrin procedure will be administered to individuals at 10- day intervals.

Injectable platelet rich fibrin Group: Only injectable platelet rich fibrin will be injected into the apical region of the mucogingival margin in alveolar mucosa of the study area.

Microneedling+ injectable platelet rich fibrin Group: After microneedling procedure is completed in keratinized tissue, injectable platelet rich fibrin will be injected into the apical region of the mucogingival margin in alveolar mucosa of the study area.

The clinical measurements of the patients will be taken once at baseline then after 1 month, 3 months, 6 months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age18- 45years.
Gingival thickness of mandibular anterior and premolars with thin gingival phenotype (â‰¤ 0.8mm.) No blood borne conditions.
Full mouth plaque index and Bleeding on probing score â‰¤15% (total score should be less than â‰¤15% of the maximum score).
Systemically healthy patients.

Exclusion Criteria

Active orthodontic treatment.
Use of tobacco in any form.
Previous periodontal surgery.
Systemic diseases.
Use of blood thinners.
Use of any drug that might lead to gingival enlargement.
Malocclusion, crowding, fillings, missing and supernumerary teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the changes in gingival thickness, keratinized tissue width, clinical attachment level and probing depth .	Baseline, 1month, 3months and 6months.

Secondary Outcome Measures

Name	Time	Method
To compare the changes in plaque index, gingival index and modified sulcular bleeding index.	Baseline, 6months

Trial Locations

Locations (1): NARAYANA DENTAL COLLEGE AND HOSPITAL
🇮🇳
Nellore, ANDHRA PRADESH, India
NARAYANA DENTAL COLLEGE AND HOSPITAL
🇮🇳Nellore, ANDHRA PRADESH, India
B NAMRATHA SAI
Principal investigator
9392214267
namrathasai2803@gmail.com