Gingival RecessionPhase 4NCT02632968
Pinhole Surgical Technique With And Without Use Of Buttons For Treatment Of Multiple Gingival Recessions: RCT
A Phase 4 study testing Pinhole surgery with and without buttons in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Pinhole surgery with and without buttons
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2013to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- American Society of Anaesthesiologists Physical Status I or II.
- No contra-indications for periodontal surgery.
- Non-Smokers.
- Patients with esthetic concerns.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krishnadevaraya College of Dental Sciences and Hospital
Bangalore, Karnataka, 562157
Joann P George, MDS, 9448541637, drjoannpaulinegeorge@gmail.com
Divya Khanna, MDS (BDS), 9910986765, drdivyakhanna31@gmail.com
About this study
Official title: Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- Pinhole surgery with and without buttons
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinhole surgery with and without buttonsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pinhole surgery with orthodontic buttons | Active comparator | Pinhole surgery with orthodontic buttons The selected participants were assigned in test and control. In the test group orthodontic buttons were cemented on the bid-buccal region of the crown with dual cure GIC. After administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions. The sling sutures 5-0 mersilk were placed to hold the tunnel in an advanced location using orthodontic buttons as anchoring units. Inter-dental sutures with 6-0 mersilk were also placed for stabilization of the advanced gingival tissue. Receives: Procedure: Pinhole surgery with and without buttons |
| Pinhole surgery without buttons | Active comparator | Pinhole surgery without orthodontic buttons The selected participants were assigned in test and control. In the control group, after administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions till the recession defects were covered. No sutures or orthodontic buttons were used in the control site. Receives: Procedure: Pinhole surgery with and without buttons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Mean Root Coverage
Measured: 6 months
Complete Root Coverage
Measured: 6 months
Root Coverage Esthetic Score
Measured: 6 months
Recession Depth Reduction
Measured: 6 months
Secondary outcomes (7)
Gingival Recession Width Reduction
Measured: 6 months
Probing Depth (PD)
Measured: 6 months
Clinical Attachment Level (CAL)
Measured: 6 months
Keratinized Tissue Width (KTW)
Measured: 6 months
Bleeding Index (BI)
Measured: 6 months
Gingival Index (GI)
Measured: 6 month
Plaque Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Joann P George, MDS, Study director, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632968
- Sponsor's protocol ID
- 02_D012_44452
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02632968
- Acronym / sponsor ID
- 02_D012_44452
- Conditions
- Gingival Recession
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinhole surgery with orthodontic buttons | Active comparator | Procedure: Pinhole surgery with and without buttonsPinhole surgery with orthodontic buttons The selected participants were assigned in test and control. In the test group orthodontic buttons were cemented on the bid-buccal region of the crown with dual cure GIC. After administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions. The sling sutures 5-0 mersilk were placed to hold the tunnel in an advanced location using orthodontic buttons as anchoring units. Inter-dental sutures with 6-0 mersilk were also placed for stabilization of the advanced gingival tissue. |
| Pinhole surgery without buttons | Active comparator | Procedure: Pinhole surgery with and without buttonsPinhole surgery without orthodontic buttons The selected participants were assigned in test and control. In the control group, after administration of LA, 2 to 3 pinhole incisions were made and a full thickness muco-periosteal tunnel was raised and collagen membrane was tucked in through the pinhole incisions till the recession defects were covered. No sutures or orthodontic buttons were used in the control site. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pinhole surgery with and without buttons | Procedure or surgery | Pinhole surgery with orthodontic buttons, Pinhole surgery without buttons |
Primary outcome
Percentage of Mean Root Coverage
Time frame: 6 months
Complete Root Coverage
Time frame: 6 months
Root Coverage Esthetic Score
Time frame: 6 months
Recession Depth Reduction
Time frame: 6 months
7 secondary outcomes
Gingival Recession Width Reduction
Time frame: 6 months
Probing Depth (PD)
Time frame: 6 months
Clinical Attachment Level (CAL)
Time frame: 6 months
Keratinized Tissue Width (KTW)
Time frame: 6 months
Bleeding Index (BI)
Time frame: 6 months
Gingival Index (GI)
Time frame: 6 month
Plaque Index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Joann P George, MDS study director
Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagara, Hunsamaranahalli, International Airport Road, Bangalore 562157
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pinhole surgery with and without buttons in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Joann P George, MDS (9448541637, drjoannpaulinegeorge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Mean Root Coverage (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.