Gingival RecessionNCT03886051
Effect of Orthodontic Treatment on the Stability of Pre-Orthodontic Recession Coverage
A study testing Connective Tissue Graft before Orthodontic treatment and Orthodontic treatment only in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study attempts to assess the effect of orthodontic treatment on the stability of pre-orthodontic recession coverage by connective tissue graft- a randomized controlled clinical trial and thus facilitate better evidence based treatment protocol. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Connective Tissue Graft before Orthodontic treatment and Orthodontic treatment only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 22 Mar 2020
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-25 yrs.
- Anterior tooth displaying Miller's class III gingival recession.
- Gingival recession depth ≥ 2mm
- Arch length tooth material discrepancy ≤ 4 mm in anterior teeth which can be treated orthodontically without indication for planned extraction.
- At the time of enrollment, the patient not having trauma from occlusion.
- Presence of clinically identifiable cementoenamel junction.
- Patient demonstrating compliance for maintaining good oral hygiene after Phase I treatment.
Who cannot join
- Patient having any systemic illness (such as diabetes, hyperthyroidism, autoimmune diseases, etc.) that is known to affect the periodontium or outcome of periodontal treatment.
- Aggressive Periodontitis
- Patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing or patients on long-term NSAIDS treatment.
- Patients allergic to medication (local anaesthetic, antibiotic, NSAID).
- Pregnant or lactating women.
- History of recent periodontal treatment within 6 months prior to the study.
Show all 14Show fewer
- Teeth Displaying Miller's class III/class IV gingival recession.
- The presence of severe cervical abrasion, erosion or root caries that would require restoration and cervically restored teeth.
- Patients indicated for planned extraction during orthodontic treatment.
- Gingival recession in due to extrusion of the tooth.
- Mobile teeth.
- Non-vital tooth.
- Smokers and tobacco chewers.
- Patients with Oral Piercing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Effect of Orthodontic Treatment on the Stability of Pre-Orthodontic Recession Coverage by Connective Tissue Graft. A Randomized Controlled Clinical Trial
This study attempts to assess the effect of orthodontic treatment on the stability of pre-orthodontic recession coverage by connective tissue graft- a randomized controlled clinical trial and thus facilitate better evidence based treatment protocol.
Read the detailed description
Gingival recession is the location of the gingival margin apical to the cemento-enamel junction. The consequences of gingival recession range from impairment of esthetics, development of dentin hypersensitivity, root caries and an especially high incidence of non-carious cervical lesions.
The etiology of gingival recession is held to be multifactorial with various predisposing and precipitating factors recognized. The most commonly implicated risk factors include bone dehiscence/fenestration, tooth malposition (especially facially positioned teeth), thin gingival phenotype, the narrow width of keratinized gingiva, frenum pull, the presence of gingival inflammation, overzealous toothbrushing, and faulty dental restorations. Apart from these, certain types of orthodontic tooth movements are also assumed to precipitate gingival recession although conclusive evidence in support of this postulation is still needed and if indeed true, the precise underlying mechanism still unclear.
Most of the studies have focused on the contribution of orthodontic treatment induced incisor proclination (outside the dentoalveolar envelope) as a causative factor for the development of gingival recession and the findings have been indecisive. While some studies support this premise, others have observed no such correlation. Correspondingly, the issue of periodontal intervention in order to prevent development and/or progression of gingival recession in patients scheduled for orthodontic treatment remains unclear. One approach supports performing gingival augmentation prior to initiation of orthodontic tooth movement. The basis for this approach rests in the concept of the importance of the minimum amount of attached gingiva needed for dissipating forces of muscle pull, unattached mucosa and masticatory stresses and facilitation of patient performed oral hygiene procedures. Esthetic improvement, management of dentinal hypersensitivity and prevention of root caries are other expected benefits specifically associated with performing root coverage surgery. Moreover, improvement of gingival tissue dimensions before orthodontic tooth movement is expected to prevent further deterioration of preexisting gingival recession and better withstand orthodontic forces. Therefore, this approach is typically a preventive one. However, supporters of the other perspective, i.e. waiting for gingival augmentation surgery until after orthodontic treatment is over believe that it is best to wait until the gingival recession develops into a pathological entity and becomes a real clinical problem warranting corrective treatment. In fact, they regard the aforementioned preventive approach as a sort of 'overtreatment' and therefore avoidable. There are also concerns expressed regarding the long-term stability of gingival marginal levels achieved with mucogingival surgery performed before orthodontic tooth movement. Based on the above discussion, it is apparent that there is wide subjectivity regarding clinical decision making in cases where orthodontic treatment is planned in patients displaying gingival recession. Currently, both the indications as well as the timing of carrying out root coverage procedures in patients scheduled for orthodontic treatment are not very well elaborated. A thorough search of the literature revealed a very modest level of evidence - one study with prospective and retrospective data collection and the other a retrospective study. In both the studies, gingival augmentation surgery was carried out before the orthodontic intervention. Therefore, a need is felt for conducting a well-designed research in order to dissipate the conflict of opinions existing over this vital clinical issue. The high prevalence of gingival recession among patients needing orthodontic treatment renders this question even more vital. The current study has thus been conceived and designed so as to help resolve this clinical decision making conundrum. In the proposed study, a comparative evaluation of clinical and radiographic parameters pre and post-orthodontic treatment in teeth with gingival recession between participants undergoing gingival recession coverage before the initiation of orthodontic tooth movement with participants not undergoing pre-orthodontic root coverage will be done. The root coverage procedure chosen is sub-epithelial connective tissue graft since it is recognized as the gold standard among all recession coverage surgical procedures.
The present prospective, analytical, randomized controlled clinical trial will be conducted in the Department of Periodontics and Oral Implantology in collaboration with Department of Orthodontics, Post Graduate Institute of Dental Sciences, Rohtak.
Systemically healthy individuals having slight crowding in the anterior region, with at least one tooth having a gingival recession in the same region.
Participants will be enlisted from the regular outpatient department of the Department of Periodontics and Oral Implantology, Department of Orthodontics and Department of Oral Medicine Diagnosis and Radiology after screening on the basis of inclusion and exclusion criteria as detailed above. All participants will be given an outline of the study design and all patient-specific considerations and concerns will be properly addressed. All participants will be required to provide written informed consent.
All patients enrolled in the study will be further randomly divided into the following two groups using computer-generated randomization table using block randomization of 4 and 6 by the random allocation software system.
- Connective Tissue Graft before Orthodontic treatment (Test Group) - Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using subepithelial connective tissue graft. Orthodontic treatment will be initiated 3 months following the grafting procedure.
- Orthodontic treatment only (Control Group) - Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.
Participants of both the groups will be regularly motivated and expected to maintain meticulous plaque control throughout the course of orthodontic treatment.
Full mouth scaling and root planning will be performed using ultrasonic instruments and hand instruments as needed. After administration of local anaesthesia, a partial-thickness flap will be reflected with a horizontal incision 2 mm away from the tip of the interdental papilla, and two vertical incisions will be made from the gingival margin of the line angles of adjoining teeth. These incisions would extend at least one tooth wider mesiodistally than the area of gingival recession. The incisions will be extended to the mucobuccal fold. A connective tissue graft will be obtained from the palate near the gingival margin of molars and premolars. The palatal wound will be sutured to obtain primary wound closure. The connective tissue graft will then be placed on the denuded root surface and sutured to the periosteum using resorbable sutures. The outer portion of the graft will be covered with the partial thickness flap, and sutures will be placed interdentally. This will be followed by placement of periodontal dressing. All the patients will be treated with the same fixed mechanotherapy. Oral hygiene motivation and maintenance will be done during the entire course of orthodontic treatment. Once the levelling and alignment (approximately 6-8 months) of teeth has been completed, parameters will be recorded for both test group and control group.
PRIMARY OUTCOME MEASURES A) Clinical:-
- Keratinized tissue width (KTW)
- Clinical attachment level(CAL)
- Recession depth (REC)
- Recession width
- Gingival Index(GI)
- Bleeding on Probing(BOP)
SECONDARY OUTCOME MEASURES A) Clinical:-
- Plaque Index
- Root Esthetic Score(RES)
- Probing pocket depth(PPD)
- Gingival Biotype/Phenotype
- Percentage of Root coverage
- Patient-based Evaluation of pain, hypersensitivity, and ease of oral hygiene maintenance by questionnaire and Visual Analogue scale for pain (VAS).
- Radiographic:- Radiographic Investigations will be made at the start and at the end of the treatment using Customized bite blocks and parallel angle technique will be used to obtain Intra Oral periapical radiographs and measurements were calculated by using Image - J software.
DATA COLLECTION METHODS
Clinical:
Using University of North Carolina (UNC) 15 periodontal probe to measure PPD, CAL, BOP, gingival recession at 3 sites (mesiobuccal, distal buccal and midbuccal) per tooth and at 4 sites per tooth to measure PI and GI. The cemento-enamel junction will be used as a fixed reference point.
Radiographic:
Customized bite blocks and parallel angle technique will be used to obtain Intra Oral periapical radiographs and measurements were calculated by using Image- J software.
DATA MANAGEMENT AND STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to the distribution of data. If found to be normal in distribution, intragroup comparison will be done by repeated ANOVA between different time points followed by paired T-test between two-time points and inter group comparison will be done by using Independent T-test between two groups. If it is in non-normal distribution, intragroup comparison will be done by Wilcoxon signed rank test and intergroup comparison will be done by Mann-Whitney U test. The Chi-square test will be applied to analyze categoric data. Correlation and association between predictors and dependent variables will be analyzed by correlation analysis and regression analysis.
- Conditions
- Gingival Recession
- Being tested
- Connective Tissue Graft before Orthodontic treatment, Orthodontic treatment only
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue Graft before Orthodontic treatmentProcedure or surgery
Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using sub - epithelial connective tissue graft. Orthodontic treatment will be 3 months following the grafting procedure.
Orthodontic treatment onlyProcedure or surgery
Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Connective Tissue Graft before Orthodontic treatment Receives: Procedure: Connective Tissue Graft before Orthodontic treatment |
| control group | Active comparator | Orthodontic treatment only Receives: Procedure: Orthodontic treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
recession depth
- Recession depth (REC) recorded in mm from the cementoenamel junction to the crest of the gingival margin at the deepest point
Measured: approximate 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Dec 2018
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
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.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHIKHA TEWARI, Study director, Post Graduate institute of dental sciences ROHTAK,HARYANA,INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886051
- Sponsor's protocol ID
- perioloveleena
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effect of Orthodontic Treatment on the Stability of Pre-Orthodontic Recession Coverage by Connective Tissue Graft. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03886051
- Acronym / sponsor ID
- perioloveleena
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 22 Mar 2019 (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 attempts to assess the effect of orthodontic treatment on the stability of pre-orthodontic recession coverage by connective tissue graft- a randomized controlled clinical trial and thus facilitate better evidence based treatment protocol.
Detailed description
Gingival recession is the location of the gingival margin apical to the cemento-enamel junction. The consequences of gingival recession range from impairment of esthetics, development of dentin hypersensitivity, root caries and an especially high incidence of non-carious cervical lesions.
The etiology of gingival recession is held to be multifactorial with various predisposing and precipitating factors recognized. The most commonly implicated risk factors include bone dehiscence/fenestration, tooth malposition (especially facially positioned teeth), thin gingival phenotype, the narrow width of keratinized gingiva, frenum pull, the presence of gingival inflammation, overzealous toothbrushing, and faulty dental restorations. Apart from these, certain types of orthodontic tooth movements are also assumed to precipitate gingival recession although conclusive evidence in support of this postulation is still needed and if indeed true, the precise underlying mechanism still unclear.
Most of the studies have focused on the contribution of orthodontic treatment induced incisor proclination (outside the dentoalveolar envelope) as a causative factor for the development of gingival recession and the findings have been indecisive. While some studies support this premise, others have observed no such correlation. Correspondingly, the issue of periodontal intervention in order to prevent development and/or progression of gingival recession in patients scheduled for orthodontic treatment remains unclear. One approach supports performing gingival augmentation prior to initiation of orthodontic tooth movement. The basis for this approach rests in the concept of the importance of the minimum amount of attached gingiva needed for dissipating forces of muscle pull, unattached mucosa and masticatory stresses and facilitation of patient performed oral hygiene procedures. Esthetic improvement, management of dentinal hypersensitivity and prevention of root caries are other expected benefits specifically associated with performing root coverage surgery. Moreover, improvement of gingival tissue dimensions before orthodontic tooth movement is expected to prevent further deterioration of preexisting gingival recession and better withstand orthodontic forces. Therefore, this approach is typically a preventive one. However, supporters of the other perspective, i.e. waiting for gingival augmentation surgery until after orthodontic treatment is over believe that it is best to wait until the gingival recession develops into a pathological entity and becomes a real clinical problem warranting corrective treatment. In fact, they regard the aforementioned preventive approach as a sort of 'overtreatment' and therefore avoidable. There are also concerns expressed regarding the long-term stability of gingival marginal levels achieved with mucogingival surgery performed before orthodontic tooth movement. Based on the above discussion, it is apparent that there is wide subjectivity regarding clinical decision making in cases where orthodontic treatment is planned in patients displaying gingival recession. Currently, both the indications as well as the timing of carrying out root coverage procedures in patients scheduled for orthodontic treatment are not very well elaborated. A thorough search of the literature revealed a very modest level of evidence - one study with prospective and retrospective data collection and the other a retrospective study. In both the studies, gingival augmentation surgery was carried out before the orthodontic intervention. Therefore, a need is felt for conducting a well-designed research in order to dissipate the conflict of opinions existing over this vital clinical issue. The high prevalence of gingival recession among patients needing orthodontic treatment renders this question even more vital. The current study has thus been conceived and designed so as to help resolve this clinical decision making conundrum. In the proposed study, a comparative evaluation of clinical and radiographic parameters pre and post-orthodontic treatment in teeth with gingival recession between participants undergoing gingival recession coverage before the initiation of orthodontic tooth movement with participants not undergoing pre-orthodontic root coverage will be done. The root coverage procedure chosen is sub-epithelial connective tissue graft since it is recognized as the gold standard among all recession coverage surgical procedures.
The present prospective, analytical, randomized controlled clinical trial will be conducted in the Department of Periodontics and Oral Implantology in collaboration with Department of Orthodontics, Post Graduate Institute of Dental Sciences, Rohtak.
Systemically healthy individuals having slight crowding in the anterior region, with at least one tooth having a gingival recession in the same region.
Participants will be enlisted from the regular outpatient department of the Department of Periodontics and Oral Implantology, Department of Orthodontics and Department of Oral Medicine Diagnosis and Radiology after screening on the basis of inclusion and exclusion criteria as detailed above. All participants will be given an outline of the study design and all patient-specific considerations and concerns will be properly addressed. All participants will be required to provide written informed consent.
All patients enrolled in the study will be further randomly divided into the following two groups using computer-generated randomization table using block randomization of 4 and 6 by the random allocation software system.
- Connective Tissue Graft before Orthodontic treatment (Test Group) - Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using subepithelial connective tissue graft. Orthodontic treatment will be initiated 3 months following the grafting procedure.
- Orthodontic treatment only (Control Group) - Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.
Participants of both the groups will be regularly motivated and expected to maintain meticulous plaque control throughout the course of orthodontic treatment.
Full mouth scaling and root planning will be performed using ultrasonic instruments and hand instruments as needed. After administration of local anaesthesia, a partial-thickness flap will be reflected with a horizontal incision 2 mm away from the tip of the interdental papilla, and two vertical incisions will be made from the gingival margin of the line angles of adjoining teeth. These incisions would extend at least one tooth wider mesiodistally than the area of gingival recession. The incisions will be extended to the mucobuccal fold. A connective tissue graft will be obtained from the palate near the gingival margin of molars and premolars. The palatal wound will be sutured to obtain primary wound closure. The connective tissue graft will then be placed on the denuded root surface and sutured to the periosteum using resorbable sutures. The outer portion of the graft will be covered with the partial thickness flap, and sutures will be placed interdentally. This will be followed by placement of periodontal dressing. All the patients will be treated with the same fixed mechanotherapy. Oral hygiene motivation and maintenance will be done during the entire course of orthodontic treatment. Once the levelling and alignment (approximately 6-8 months) of teeth has been completed, parameters will be recorded for both test group and control group.
PRIMARY OUTCOME MEASURES A) Clinical:-
- Keratinized tissue width (KTW)
- Clinical attachment level(CAL)
- Recession depth (REC)
- Recession width
- Gingival Index(GI)
- Bleeding on Probing(BOP)
SECONDARY OUTCOME MEASURES A) Clinical:-
- Plaque Index
- Root Esthetic Score(RES)
- Probing pocket depth(PPD)
- Gingival Biotype/Phenotype
- Percentage of Root coverage
- Patient-based Evaluation of pain, hypersensitivity, and ease of oral hygiene maintenance by questionnaire and Visual Analogue scale for pain (VAS).
- Radiographic:- Radiographic Investigations will be made at the start and at the end of the treatment using Customized bite blocks and parallel angle technique will be used to obtain Intra Oral periapical radiographs and measurements were calculated by using Image - J software.
DATA COLLECTION METHODS
Clinical:
Using University of North Carolina (UNC) 15 periodontal probe to measure PPD, CAL, BOP, gingival recession at 3 sites (mesiobuccal, distal buccal and midbuccal) per tooth and at 4 sites per tooth to measure PI and GI. The cemento-enamel junction will be used as a fixed reference point.
Radiographic:
Customized bite blocks and parallel angle technique will be used to obtain Intra Oral periapical radiographs and measurements were calculated by using Image- J software.
DATA MANAGEMENT AND STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to the distribution of data. If found to be normal in distribution, intragroup comparison will be done by repeated ANOVA between different time points followed by paired T-test between two-time points and inter group comparison will be done by using Independent T-test between two groups. If it is in non-normal distribution, intragroup comparison will be done by Wilcoxon signed rank test and intergroup comparison will be done by Mann-Whitney U test. The Chi-square test will be applied to analyze categoric data. Correlation and association between predictors and dependent variables will be analyzed by correlation analysis and regression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: Connective Tissue Graft before Orthodontic treatmentConnective Tissue Graft before Orthodontic treatment |
| control group | Active comparator | Procedure: Orthodontic treatment onlyOrthodontic treatment only |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 16-25 yrs.
- Anterior tooth displaying Miller's class III gingival recession.
- Gingival recession depth ≥ 2mm
- Arch length tooth material discrepancy ≤ 4 mm in anterior teeth which can be treated orthodontically without indication for planned extraction.
- At the time of enrollment, the patient not having trauma from occlusion.
Key exclusion criteria (14 listed)
- Patient having any systemic illness (such as diabetes, hyperthyroidism, autoimmune diseases, etc.) that is known to affect the periodontium or outcome of periodontal treatment.
- Aggressive Periodontitis
- Patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing or patients on long-term NSAIDS treatment.
- Patients allergic to medication (local anaesthetic, antibiotic, NSAID).
- Pregnant or 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 |
|---|---|---|
| Connective Tissue Graft before Orthodontic treatmentScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using sub - epithelial connective tissue graft. Orthodontic treatment will be 3 months following the grafting procedure. | Procedure or surgery | test group |
| Orthodontic treatment onlyScaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated. | Procedure or surgery | control group |
Primary outcome
recession depth
Time frame: approximate 14 months
• Recession depth (REC) recorded in mm from the cementoenamel junction to the crest of the gingival margin at the deepest point
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 8 Apr 2021.
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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.
SHIKHA TEWARI study director
Post Graduate institute of dental sciences ROHTAK,HARYANA,INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Graft before Orthodontic treatment and Orthodontic treatment only in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak 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 7 inclusion and 14 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 8 Apr 2021. 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?
recession depth (time frame: approximate 14 months). 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 8 Apr 2021.