Gingival Recession, LocalizedCCMMRCLDFNCT03654339
Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap
A study testing root coverage in people with Gingival Recession, Localized, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using the laterally repositioned flap Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- root coverage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 24 Aug 2017to 16 Aug 2018
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-50 yrs
- ClassII gingival recession
- Vital teeth that were free from caries or inadequate restorations
- Sufficient width of attached gingiva
Who cannot join
- Any systemic diseases and smokers
- ClassI,III\&IV gingival recession
- Abnormal frenal attachments
- Interdental bone loss with tooth mobility
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidyalaya Institute of Dental Sciences
Hyderabad, Telangana, 500060
About this study
Official title: Comparison of Conventional vs Microsurgical Method for Root Coverage by Lateral Displacement Flap
This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using the laterally repositioned flap
Read the detailed description
In this study total, 30 patients were selected The patients initially received a comprehensive periodontal examination and complete plaque control program including oral hygiene to eliminate habits related to the aetiology of recession. Scaling, root planning and occlusal adjustments were done The patients were randomly assigned and divided into two groups. Group A and Group B. Patients with miller class II were treated with a laterally repositioned flap to obtain root coverage using conventional macrosurgical approach (15patients) and microsurgical approach(15patients)
The clinical parameters evaluated were height of gingival recession relative clinical attachment level which was measured as the distance from a fixed point in a stent to the bottom of the pocket and gingival biotype at baseline, 3 months and 6 months period
- Conditions
- Gingival Recession, Localized
- Being tested
- root coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root coverageProcedure or surgery
Group A: After administration of local anaesthesia using ophthalmic microsurgical knives a V-shaped incision was made in the gingival recession area. the gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then secured with 6-0 absorbable sling suture without tension. the surgical procedure was done with seilar microscope 40X magnification.
Group B: After administration of local anaesthesia using 15 no blade a V-shaped incision was made in the gingival recession area . gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then carefully secured with 4-0 absorbable sling suture
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Group A-15 patients were allocated to the microsurgical group for root coverage. following scaling and root planning, the laterally repositioned flap was done using the microsurgical approach
Group B-15 Patients were allocated to the conventional group for root coverage following scaling and root planning, the laterally repositioned flap was done using the macrosurgical approach Receives: Procedure: root coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical depth of recession
The height of gingival recession: From cementoenamel junction to the free gingival margin.
Measured: Change in level of gingival margin from baseline to 6 months.
Secondary outcomes (1)
horizontal width of recession
The width of gingival recession: Horizontal dimension of gingival defect at the level of Cementoenamel junction..
Measured: Change in horizontal dimension of gingival margin from baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start24 Aug 2017
- Primary completion31 Mar 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will be equally divided into two test groups. Group A and Group B after phase I therapy. the group A patients will be treated with laterally repositioned flap to obtain root coverage using microsurgical approach. The group B patients will be treated with laterally repositioned flap to obtain root coverage using macrosurgical approach
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.A.Kranthi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- veerendranath reddy, MDS, Study director, panineeya mahavidyalaya institute of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654339
- Sponsor's protocol ID
- kranthirecession
- Acronym
- CCMMRCLDF
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nizam N, Bengisu O, Sonmez S. Micro- and macrosurgical techniques in the coverage of gingival recession using connective tissue graft: 2 years follow-up. J Esthet Restor Dent. 2015 Mar-Apr;27(2):71-83. doi: 10.1111/jerd.12124. Epub 2014 Nov 13.
PubMed 25393983
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional vs Microsurgical Method for Root Coverage by Lateral Displacement Flap
- ClinicalTrials.gov ID
- NCT03654339
- Acronym / sponsor ID
- CCMMRCLDF / kranthirecession
- Conditions
- Gingival Recession, Localized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using the laterally repositioned flap
Detailed description
In this study total, 30 patients were selected The patients initially received a comprehensive periodontal examination and complete plaque control program including oral hygiene to eliminate habits related to the aetiology of recession. Scaling, root planning and occlusal adjustments were done The patients were randomly assigned and divided into two groups. Group A and Group B. Patients with miller class II were treated with a laterally repositioned flap to obtain root coverage using conventional macrosurgical approach (15patients) and microsurgical approach(15patients)
The clinical parameters evaluated were height of gingival recession relative clinical attachment level which was measured as the distance from a fixed point in a stent to the bottom of the pocket and gingival biotype at baseline, 3 months and 6 months period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will be equally divided into two test groups. Group A and Group B after phase I therapy. the group A patients will be treated with laterally repositioned flap to obtain root coverage using microsurgical approach. The group B patients will be treated with laterally repositioned flap to obtain root coverage using macrosurgical approach
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: root coverageGroup A-15 patients were allocated to the microsurgical group for root coverage. following scaling and root planning, the laterally repositioned flap was done using the microsurgical approach Group B-15 Patients were allocated to the conventional group for root coverage following scaling and root planning, the laterally repositioned flap was done using the macrosurgical approach |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-50 yrs
- ClassII gingival recession
- Vital teeth that were free from caries or inadequate restorations
- Sufficient width of attached gingiva
Key exclusion criteria (4 listed)
- Any systemic diseases and smokers
- ClassI,III\&IV gingival recession
- Abnormal frenal attachments
- Interdental bone loss with tooth mobility
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 |
|---|---|---|
| root coverageGroup A: After administration of local anaesthesia using ophthalmic microsurgical knives a V-shaped incision was made in the gingival recession area. the gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then secured with 6-0 absorbable sling suture without tension. the surgical procedure was done with seilar microscope 40X magnification. Group B: After administration of local anaesthesia using 15 no blade a V-shaped incision was made in the gingival recession area . gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then carefully secured with 4-0 absorbable sling suture | Procedure or surgery | experimental group |
Primary outcome
vertical depth of recession
Time frame: Change in level of gingival margin from baseline to 6 months.
The height of gingival recession: From cementoenamel junction to the free gingival margin.
1 secondary outcome
horizontal width of recession
Time frame: Change in horizontal dimension of gingival margin from baseline to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Results publication: PubMed 25393983Nizam N, Bengisu O, Sonmez S. Micro- and macrosurgical techniques in the coverage of gingival recession using connective tissue graft: 2 years follow-up. J Esthet Restor Dent. 2015 Mar-Apr;27(2):71-83. doi: 10.1111/jerd.12124. Epub 2014 Nov 13.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recession, Localized
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
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
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized
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.
veerendranath reddy, MDS study director
panineeya mahavidyalaya institute of dental sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root coverage in people with Gingival Recession, Localized, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Sep 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical depth of recession (time frame: Change in level of gingival margin from baseline to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654339, which also lists 1 linked publication.
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 4 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.