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Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT

Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02632968
Enrollment
80
Registered
2015-12-17
Start date
2013-11-30
Completion date
2016-03-31
Last updated
2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

PROCEDUREPinhole surgery with and without buttons

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Percentage of Mean Root Coverage6 months
Complete Root Coverage6 months
Root Coverage Esthetic Score6 months
Recession Depth Reduction6 months

Secondary

MeasureTime frame
Bleeding Index (BI)6 months
Gingival Recession Width Reduction6 months
Plaque Index6 months
Gingival Index (GI)6 month
Probing Depth (PD)6 months
Clinical Attachment Level (CAL)6 months
Keratinized Tissue Width (KTW)6 months

Countries

India

Contacts

Primary ContactDr. Joann P George, MDS
drjoannpaulinegeorge@gmail.com9448541637
Backup ContactDr. Divya Khanna, MDS (BDS)
drdivyakhanna31@gmail.com9910986765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026