Clinical trial NCT02632968: Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT
Official title: Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gingival Recession
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and cost-effective technique for treatment of multiple gingival recession. This procedure involves no releasing incision, suturing or sharp dissections. It has been shown that the greater post-operative displacement of gingival margin may cause greater root coverage. Based on this hypothesis, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

Detailed description: To achieve multiple adjacent recession coverage and an optimal integration of the associated tissues is even more challenging and a complex endeavour in comparison to isolated gingival recessions. Treatment protocol and outcome with different surgical procedures depends on a variety of factors like recession, defect size, presence or absence of keratinized tissue adjacent to the defect, width and height of inter-dental soft tissue, depth of vestibule, presence of frenum, post-operative stabilization and final position of advanced gingival margin. The final position of the GM plays a critical role in achieving CRC. Based on this hypothesis, a split mouth clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

METHOD The aim of this split-mouth randomized controlled clinical trial was to clinically compare and evaluate the effectiveness and predictability of Pinhole surgical technique alone and its modification with orthodontic buttons and sutures in 80 sites for the treatment of multiple gingival recessions and to assess the influence of these surgical procedures on the gingival and periodontal health, in the maxillary arch for six months post surgically. Gingival recession depth (GRD), Gingival margin location post-surgery, Gingival recession width (GRW), Root coverage esthetic score (RES), Complete root coverage (CRC), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Multiple (atleast two or three) Millers class I and II or combined class I and II recession defects18 affecting adjacent teeth of the maxillary arch.
* Patients with thick gingival biotypes \>0.8mm.
* Presence of adequate keratinized tissue apical to recession \> 1mm.
* Age group 25-55 years.
* Patients with history of compliance to oral hygiene instructions and a full mouth plaque score of \<10%.
* Patients willing to participate in the study.
* American Society of Anaesthesiologists Physical Status I or II.
* No contra-indications for periodontal surgery.
* Non-Smokers.
* Patients with esthetic concerns.

Exclusion Criteria:

* Recession defects associated with caries/demineralization, restorations, and deep abrasions (step \>2mm).
* No occlusal interferences.
* Teeth with evidence of pulpal pathology.
* Patients who have undergone any previous periodontal surgical procedures at the involved sites.
* Pregnant and lactating women.
* Patients on medications known to interfere with periodontal tissue health or healing.

Primary outcomes:
measure: Percentage of Mean Root Coverage
timeFrame: 6 months
measure: Complete Root Coverage
timeFrame: 6 months
measure: Root Coverage Esthetic Score
timeFrame: 6 months
measure: Recession Depth Reduction
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Recession Width Reduction
timeFrame: 6 months
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months
measure: Keratinized Tissue Width (KTW)
timeFrame: 6 months
measure: Bleeding Index (BI)
timeFrame: 6 months
measure: Gingival Index (GI)
timeFrame: 6 month
measure: Plaque Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya College of Dental Sciences and Hospital
state: Karnataka
Study officials:
affiliation: Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
name: Dr. Joann P George, MDS
role: STUDY_DIRECTOR
References: