Gingival RecessionPhase 4NCT02835430
Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession
A Phase 4 study testing Coronally advanced flap and PRF with DFDBA and Coronally advanced flap and PRF without DFDBA in people with Gingival Recession, run by Dr. D. Y. Patil Dental College & Hospital.
Trial summary
Gingival recession is defined as the apical migration of gingival margin beyond cemento-enamel junction with the exposure of root surface. More than 20% of the population presents one or more tooth surfaces with gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally advanced flap and PRF with DFDBA and Coronally advanced flap and PRF without DFDBA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group of 18-45 years from both sexes.
- Presence of bilateral isolated gingival recession classified as Miller's class I or class II recession defects in anteriors and/or premolars.
- Systemically healthy patients.
- Patients willing to comply with all study-related procedures and available for follow-up.
- Ability to maintain good oral hygiene.
Who cannot join
- History of prolonged use of antibiotics/steroids/immunosuppressive agents/aspirin/ anticoagulants/other medications.
- Pregnant/Lactating women.
- Tobacco in any form.
- History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer.
- Patients with unacceptable oral hygiene.
- Faulty tooth brushing technique.
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- Malaligned teeth.
- Cervical abrasion.
- Unwilling patients.
About this study
- Gingival recession is defined as the apical migration of gingival margin beyond cemento-enamel junction with the exposure of root surface. More than 20% of the population presents one or more tooth surfaces with gingival recession.
- The main conditions leading to the development of this defect are gingival anatomical factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.
- The main goal of treating gingival recession is to restore the gingival margin to cement-enamel junction (CEJ) and normal sulcus with a functional attachment.
- A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that contains growth factors and cicatricial properties for root coverage procedures.
- Space is necessary to provide a channel for the migration of progenitor cells towards and on the denuded root surface, where they can differentiate into cementum and periodontal ligament cells.
- Since the gingival recession defects are non-space making, it may be difficult using the membrane technique alone, and hence, the use of a graft material underneath the membrane may help to resolve this problem. Root coverage tended to be better with the addition of demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells, and are thus, capable of promoting regeneration of attachment apparatus.
- Till date, no study is available in the literature on clinical evaluation of CAF (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession defects.
- And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky Mountain Particulate Allograft) for the management of isolated gingival recession defects.
Read the detailed description
SURGICAL PROCEDURE:
- After patient selection and obtaining informed consent, a total of 10 bilateral facial, Miller's Class I or II gingival recession defects were consecutively treated. Test and Control site were randomly assigned by flip coin technique.
II. The Test sites were treated using CAF+PRF+DFDBA and the Control sites were treated using CAF+PRF.
III. Under local anesthesia, an intrasulcular incision was given using a surgical bade on the buccal aspect of the involved tooth. The incision was extended horizontally to dissect the buccal aspect of the adjacent papillae, both mesially and distally, leaving the gingival margin of the adjacent teeth untouched. Two oblique releasing incisions were made from the mesial and distal extremities of the horizontal incision beyond the mucogingival junction.
IV. Partial-full-partial thickness flap was raised and extended beyond the mucogingival junction. The exposed root surface was thoroughly debrided and prepared to reduce the root convexities, if any.
- A mesio-distal and apical dissection parallel to the vestibular lining mucosa was performed to release the residual muscle tension and facilitate the passive coronal displacement of the flap. The papillae adjacent to the involved tooth was de-epithelialized.
Preparation of PRF:
Preoperatively, a 10 ml of blood sample of the patient without anticoagulant was collected in a test tube and centrifuged immediately at 3000 rpm for 10 minutes. The platelet-rich fibrin clot was separated from the other two layers (acellular plasma and red blood cells) and prepared in the form of a membrane by squeezing out fluids from the fibrin clot.
. For Test site: i. Following pre-suturing, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane.
ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture.
iii. Additional lateral sutures were placed to close the releasing incisions.
. For Control site: i. Following pre-suturing, exposed root and adjacent bone surfaces were covered by PRF membrane.
ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture.
iii. Additional lateral sutures were placed to close the releasing incisions.
Post-surgical protocols:
Postoperative instructions were given along with a recommendation to refrain from mechanical cleaning on the surgical areas. Periodontal dressing was placed at both Test and Control sites. Patients were instructed to apply 0.12% chlorhexidine solution (1:1 dilution) with a cotton swab twice daily for 14 days. Analgesics and antibiotics were prescribed and suture removal was performed 14 days post-surgery.
- Conditions
- Gingival Recession
- Being tested
- Coronally advanced flap and PRF with DFDBA, Coronally advanced flap and PRF without DFDBA
- Keywords
- Coronally advanced flap, Gingival recession, Bone, demineralized, Bone, freeze-dried, platelet-rich fibrin, root coverage procedures
- Medical subject headings
- Gingival Recession, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap and PRF with DFDBAProcedure or surgery
Also called Coronally advanced flap and Platelet-Rich Fibrin (PRF) with demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)
- For Test site: i. Following pre-suturing of coronally advanced flap, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane.
Coronally advanced flap and PRF without DFDBAProcedure or surgery
Also called Coronally advanced flap and Platelet-Rich Fibrin (PRF) without demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)
. For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane.
| Study group | Role | What they receive |
|---|---|---|
| Coronally advanced flap and PRF with DFDBA | Experimental | Coronally advanced flap and platelet-rich fibrin membrane with demineralized freeze-dried bone allograft. Receives: Procedure: Coronally advanced flap and PRF with DFDBA |
| Coronally advanced flap and PRF without DFDBA | Active comparator | Coronally advanced flap and Platelet-rich fibrin membrane without demineralized freeze-dried bone allograft. Receives: Procedure: Coronally advanced flap and PRF without DFDBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Depth (RD)
Recession depth (RD), measured from the cemento-enamel junction (CEJ) to the most apical extension of gingival margin at Baseline and 6 months post-surgery.
Measured: Change from Baseline Recession Depth at 6 months.
Secondary outcomes (4)
Relative Attachment Level (RAL)
Relative Attachment Level from the lower border of stent to the base of sulcus at Baseline and 6 months post-surgery.
Measured: Change from Baseline Relative Attachment Level at 6 months.
Probing Depth
Probing depth was recorded from the crest of gingival margin to the base of gingival sulcus at Baseline and 6 months post-surgery.
Measured: Change from Baseline Probing Depth at 6 months.
Width of Keratinized Gingiva (WKG)
Width of Keratinized Gingiva (WKG) measured from the gingival margin to the mucogingival junction at Baseline and 6 months post-surgery.
Measured: Change from Baseline Width of Keratinized Gingiva at 6 months.
Percentage of Root Coverage
(Preoperative recession depth - Postoperative recession depth)/ Preoperative recession depth * 100, at 6 months post-surgery.
Measured: At 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startNov 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, POONAM DHOLAKIA, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835430
- Sponsor's protocol ID
- DPU/831(11)/2014
- Status last verified
- Jul 2016
- First submitted
- 9 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Padma R, Shilpa A, Kumar PA, Nagasri M, Kumar C, Sreedhar A. A split mouth randomized controlled study to evaluate the adjunctive effect of platelet-rich fibrin to coronally advanced flap in Miller's class-I and II recession defects. J Indian Soc Periodontol. 2013 Sep;17(5):631-6. doi: 10.4103/0972-124X.119281.
PubMed 24174758Nanditha S, Priya MS, Sabitha S, Arun KV, Avaneendra T. Clinical evaluation of the efficacy of a GTR membrane (HEALIGUIDE) and demineralised bone matrix (OSSEOGRAFT) as a space maintainer in the treatment of Miller's Class I gingival recession. J Indian Soc Periodontol. 2011 Apr;15(2):156-60. doi: 10.4103/0972-124X.84386.
PubMed 21976841
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession
- ClinicalTrials.gov ID
- NCT02835430
- Acronym / sponsor ID
- DPU/831(11)/2014
- Conditions
- Gingival Recession
- Keywords
- Coronally advanced flap, Gingival recession, Bone, demineralized, Bone, freeze-dried, platelet-rich fibrin, root coverage procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jul 2016 (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.
- Gingival recession is defined as the apical migration of gingival margin beyond cemento-enamel junction with the exposure of root surface. More than 20% of the population presents one or more tooth surfaces with gingival recession.
- The main conditions leading to the development of this defect are gingival anatomical factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.
- The main goal of treating gingival recession is to restore the gingival margin to cement-enamel junction (CEJ) and normal sulcus with a functional attachment.
- A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that contains growth factors and cicatricial properties for root coverage procedures.
- Space is necessary to provide a channel for the migration of progenitor cells towards and on the denuded root surface, where they can differentiate into cementum and periodontal ligament cells.
- Since the gingival recession defects are non-space making, it may be difficult using the membrane technique alone, and hence, the use of a graft material underneath the membrane may help to resolve this problem. Root coverage tended to be better with the addition of demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells, and are thus, capable of promoting regeneration of attachment apparatus.
- Till date, no study is available in the literature on clinical evaluation of CAF (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession defects.
- And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky Mountain Particulate Allograft) for the management of isolated gingival recession defects.
Detailed description
SURGICAL PROCEDURE:
- After patient selection and obtaining informed consent, a total of 10 bilateral facial, Miller's Class I or II gingival recession defects were consecutively treated. Test and Control site were randomly assigned by flip coin technique.
II. The Test sites were treated using CAF+PRF+DFDBA and the Control sites were treated using CAF+PRF.
III. Under local anesthesia, an intrasulcular incision was given using a surgical bade on the buccal aspect of the involved tooth. The incision was extended horizontally to dissect the buccal aspect of the adjacent papillae, both mesially and distally, leaving the gingival margin of the adjacent teeth untouched. Two oblique releasing incisions were made from the mesial and distal extremities of the horizontal incision beyond the mucogingival junction.
IV. Partial-full-partial thickness flap was raised and extended beyond the mucogingival junction. The exposed root surface was thoroughly debrided and prepared to reduce the root convexities, if any.
- A mesio-distal and apical dissection parallel to the vestibular lining mucosa was performed to release the residual muscle tension and facilitate the passive coronal displacement of the flap. The papillae adjacent to the involved tooth was de-epithelialized.
Preparation of PRF:
Preoperatively, a 10 ml of blood sample of the patient without anticoagulant was collected in a test tube and centrifuged immediately at 3000 rpm for 10 minutes. The platelet-rich fibrin clot was separated from the other two layers (acellular plasma and red blood cells) and prepared in the form of a membrane by squeezing out fluids from the fibrin clot.
. For Test site: i. Following pre-suturing, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane.
ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture.
iii. Additional lateral sutures were placed to close the releasing incisions.
. For Control site: i. Following pre-suturing, exposed root and adjacent bone surfaces were covered by PRF membrane.
ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture.
iii. Additional lateral sutures were placed to close the releasing incisions.
Post-surgical protocols:
Postoperative instructions were given along with a recommendation to refrain from mechanical cleaning on the surgical areas. Periodontal dressing was placed at both Test and Control sites. Patients were instructed to apply 0.12% chlorhexidine solution (1:1 dilution) with a cotton swab twice daily for 14 days. Analgesics and antibiotics were prescribed and suture removal was performed 14 days post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronally advanced flap and PRF with DFDBA | Experimental | Procedure: Coronally advanced flap and PRF with DFDBACoronally advanced flap and platelet-rich fibrin membrane with demineralized freeze-dried bone allograft. |
| Coronally advanced flap and PRF without DFDBA | Active comparator | Procedure: Coronally advanced flap and PRF without DFDBACoronally advanced flap and Platelet-rich fibrin membrane without demineralized freeze-dried bone allograft. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group of 18-45 years from both sexes.
- Presence of bilateral isolated gingival recession classified as Miller's class I or class II recession defects in anteriors and/or premolars.
- Systemically healthy patients.
- Patients willing to comply with all study-related procedures and available for follow-up.
- Ability to maintain good oral hygiene.
Key exclusion criteria (9 listed)
- History of prolonged use of antibiotics/steroids/immunosuppressive agents/aspirin/ anticoagulants/other medications.
- Pregnant/Lactating women.
- Tobacco in any form.
- History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer.
- Patients with unacceptable oral hygiene.
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 |
|---|---|---|
| Coronally advanced flap and PRF with DFDBAAlso: Coronally advanced flap and Platelet-Rich Fibrin (PRF) with demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)• For Test site: i. Following pre-suturing of coronally advanced flap, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane. | Procedure or surgery | Coronally advanced flap and PRF with DFDBA |
| Coronally advanced flap and PRF without DFDBAAlso: Coronally advanced flap and Platelet-Rich Fibrin (PRF) without demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft). For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane. | Procedure or surgery | Coronally advanced flap and PRF without DFDBA |
Primary outcome
Recession Depth (RD)
Time frame: Change from Baseline Recession Depth at 6 months.
Recession depth (RD), measured from the cemento-enamel junction (CEJ) to the most apical extension of gingival margin at Baseline and 6 months post-surgery.
4 secondary outcomes
Relative Attachment Level (RAL)
Time frame: Change from Baseline Relative Attachment Level at 6 months.
Probing Depth
Time frame: Change from Baseline Probing Depth at 6 months.
Width of Keratinized Gingiva (WKG)
Time frame: Change from Baseline Width of Keratinized Gingiva at 6 months.
Percentage of Root Coverage
Time frame: At 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 19 Jul 2016.
- Background: PubMed 24174758Padma R, Shilpa A, Kumar PA, Nagasri M, Kumar C, Sreedhar A. A split mouth randomized controlled study to evaluate the adjunctive effect of platelet-rich fibrin to coronally advanced flap in Miller's class-I and II recession defects. J Indian Soc Periodontol. 2013 Sep;17(5):631-6. doi: 10.4103/0972-124X.119281.
- Background: PubMed 21976841Nanditha S, Priya MS, Sabitha S, Arun KV, Avaneendra T. Clinical evaluation of the efficacy of a GTR membrane (HEALIGUIDE) and demineralised bone matrix (OSSEOGRAFT) as a space maintainer in the treatment of Miller's Class I gingival recession. J Indian Soc Periodontol. 2011 Apr;15(2):156-60. doi: 10.4103/0972-124X.84386.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronally advanced flap and PRF with DFDBA and Coronally advanced flap and PRF without DFDBA in people with Gingival Recession, run by Dr. D. Y. Patil Dental College & Hospital.
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 5 inclusion and 9 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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 (RD) (time frame: Change from Baseline Recession Depth at 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 NCT02835430, which also lists 2 linked publications.
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 19 Jul 2016.