Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272006
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-11
Brief Title:
The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession The main questions it aims to answer are
Which treatment method Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft is more effective in treating gum recession How does the Anatomical Recession Rate a new measurement technique help in evaluating the success of these treatments
The patients will be treated with coronally advanced flap or modified coronally advanced tunnel connective tissue graft to see which method is more effective in reducing gum recession as measured by using anatomical recession rate
Which treatment method Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft is more effective in treating gum recession How does the Anatomical Recession Rate a new measurement technique help in evaluating the success of these treatments
The patients will be treated with coronally advanced flap or modified coronally advanced tunnel connective tissue graft to see which method is more effective in reducing gum recession as measured by using anatomical recession rate
Detailed Description:
The aim of this study is to evaluate the success of gingival recession treatment methods of coronally advanced flap CAF and modified coronally advanced tunnel MCAT by using the anatomical ratio rate ARR In the parallel-group two-arm randomized clinical study 40 randomly assigned participants into CAF and MCAT groups will be enrolled The assessor and investigator will be masked to the interventions that will be applied
Intervention CAF After local anesthesia the recipient area will be prepared by making a vertical incision from the mesial andor distal of the last tooth areas where the recession ends and by applying split-full-split-thickness incisions along with sulcular and subpapillary incisions thus releasing the flap to facilitate coronal movement Afterwards the anatomical papillae will be deepithelised and the recipient area preparation will be completed by applying SRP to the root surfaces Then CTG will be harvested from the palatal region by measuring the dimensions of the recession defect The obtained CTG will be placed on the root surface and sutured to the anatomical papillae with the resorbable sutures Then the flap will be sutured to the anatomical papillae with suspended sutures completely covering the connective tissue graft Finally vertical incisions will be sutured to easily coronally position the flap Intervention MCAT A split-thickness envelope flap will be created by performing supraperiosteal undermining with tunnel blades and elevators along the facial surface of the papilla Undermining will be extended to the apical part of the mucogingival line In order to coronally position the flap the papillary region will be elevated in full thickness and a supraperiosteal envelope recipient bed will be created Then CTG will be obtained according to the size of the recession defect from the palatal region and placed under the tunnel with guide sutures and positioned on the root surfaces and then the envelope flap will be sutured by pulling it coronally with double cross sutures to completely cover the CTG
Primary Outcome Measure
Anatomical Recession Rate ARR The primary outcome measure is the Anatomical Recession Rate ARR which quantifies the effectiveness of the Coronally Positioned Flap CPF with Connective Tissue Graft CTG and the Modified Coronally Advanced Tunnel MCAT with CTG in covering exposed root surfaces ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment with improvements in ARR indicating successful root coverage Time Frame 12 months post-treatment
Secondary Outcome Measures
Clinical Attachment Level CAL This secondary outcome measures the change in the clinical attachment level indicating the health of the periodontal tissue and its attachment to the tooth root CAL is a critical parameter for assessing periodontal health and the success of root coverage procedures Time Frame Baseline 3 6 and 12 months post-treatment
Gingival Thickness GT This outcome assesses the change in gingival thickness measured in millimeters post-treatment Increased gingival thickness is associated with better prognosis and sustainability of the root coverage Time Frame Baseline and 12 months post-treatment
Keratinized Tissue Thickness KTT This secondary outcome measures the change in keratinized tissue thickness indicating the improvement in the quantity of keratinized gum tissue post-treatment An increase in KTT is considered beneficial for periodontal health and stability as thicker keratinized tissue can better protect underlying bone and tooth roots from bacterial invasion and mechanical trauma The thickness will be measured using a periodontal probe or ultrasound device providing a quantitative assessment of the treatments effectiveness in enhancing gum tissue resilience Time Frame Baseline 3 6 and 12 months post-treatment
Wound healing index WHI This outcome will be recorded after surgery using the following criteria score 1 uneventful healing with no edema erythema suppuration discomfort or dehiscence score 2 uneventful healing with slight edema erythema discomfort or dehiscence but no suppuration and score 3 poor healing with significant edema erythema discomfort flap dehiscence or suppuration Time Frame 2 weeks post-treatment
Tissue appearance This parameter will be scored according to the consistency contour color match keloid formation degree and contiguity of the treated sites at T3 Consistency will be rated as firm 1p or spongy 0p contour as the presence 2p or absence 0p of knife-edged and scalloped GM color match as excellent 3p good 2p adequate 1p or unsatisfactory 0p keloid formation degree as absent 1p or present 0p and contiguity as the presence 1p or absence 0p of each perceptible incision mark Time Frame 6 and 12 months post-treatment
Aesthetic evaluation Aesthetics will be evaluated according to the five variables of root coverage esthetic score RES GM position marginal tissue contour MTC soft tissue texture STT MGJ alignment and gingival color GC GM position was scored as 0 3 or 6 whereas each other variable was scored as 0 or 1 Time Frame 6 and 12 months post-treatment
Dentin hypersensitivity Hypersensitivity will be recorded using a visual analog scale VAS 0 no pain 10 extreme pain after 3-s air blast applied to the cervical portions of the included sites from a triple syringe Time Frame Baseline 6 and 12 months post-treatment
Eligibility criteria Minimum Age 18 Years Maximum Age 60 Years Sex All Gender Based No Accepts Healthy Volunteers Yes
Inclusion Criteria
Participants aged 18 to 60 years Individuals with the gingival recession of Miller Class I II or III in at least one tooth in the anterior mandibular or maxillary region
Participants must have at least 1 mm of keratinized tissue width around the affected toothtooth and be in good general health
Ability to provide informed consent for participation in the study
Exclusion Criteria
Individuals with uncontrolled systemic diseases that could impact periodontal healing eg diabetes mellitus cardiovascular diseases
Current smokers or those who have quit smoking less than 6 months before the study
Women who are pregnant or breastfeeding Participants who have received periodontal or gingival recession treatment in the study area within the last year
Presence of acute periodontal or dental infections requiring immediate treatment or extensive caries affecting the study teeth
Intervention CAF After local anesthesia the recipient area will be prepared by making a vertical incision from the mesial andor distal of the last tooth areas where the recession ends and by applying split-full-split-thickness incisions along with sulcular and subpapillary incisions thus releasing the flap to facilitate coronal movement Afterwards the anatomical papillae will be deepithelised and the recipient area preparation will be completed by applying SRP to the root surfaces Then CTG will be harvested from the palatal region by measuring the dimensions of the recession defect The obtained CTG will be placed on the root surface and sutured to the anatomical papillae with the resorbable sutures Then the flap will be sutured to the anatomical papillae with suspended sutures completely covering the connective tissue graft Finally vertical incisions will be sutured to easily coronally position the flap Intervention MCAT A split-thickness envelope flap will be created by performing supraperiosteal undermining with tunnel blades and elevators along the facial surface of the papilla Undermining will be extended to the apical part of the mucogingival line In order to coronally position the flap the papillary region will be elevated in full thickness and a supraperiosteal envelope recipient bed will be created Then CTG will be obtained according to the size of the recession defect from the palatal region and placed under the tunnel with guide sutures and positioned on the root surfaces and then the envelope flap will be sutured by pulling it coronally with double cross sutures to completely cover the CTG
Primary Outcome Measure
Anatomical Recession Rate ARR The primary outcome measure is the Anatomical Recession Rate ARR which quantifies the effectiveness of the Coronally Positioned Flap CPF with Connective Tissue Graft CTG and the Modified Coronally Advanced Tunnel MCAT with CTG in covering exposed root surfaces ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment with improvements in ARR indicating successful root coverage Time Frame 12 months post-treatment
Secondary Outcome Measures
Clinical Attachment Level CAL This secondary outcome measures the change in the clinical attachment level indicating the health of the periodontal tissue and its attachment to the tooth root CAL is a critical parameter for assessing periodontal health and the success of root coverage procedures Time Frame Baseline 3 6 and 12 months post-treatment
Gingival Thickness GT This outcome assesses the change in gingival thickness measured in millimeters post-treatment Increased gingival thickness is associated with better prognosis and sustainability of the root coverage Time Frame Baseline and 12 months post-treatment
Keratinized Tissue Thickness KTT This secondary outcome measures the change in keratinized tissue thickness indicating the improvement in the quantity of keratinized gum tissue post-treatment An increase in KTT is considered beneficial for periodontal health and stability as thicker keratinized tissue can better protect underlying bone and tooth roots from bacterial invasion and mechanical trauma The thickness will be measured using a periodontal probe or ultrasound device providing a quantitative assessment of the treatments effectiveness in enhancing gum tissue resilience Time Frame Baseline 3 6 and 12 months post-treatment
Wound healing index WHI This outcome will be recorded after surgery using the following criteria score 1 uneventful healing with no edema erythema suppuration discomfort or dehiscence score 2 uneventful healing with slight edema erythema discomfort or dehiscence but no suppuration and score 3 poor healing with significant edema erythema discomfort flap dehiscence or suppuration Time Frame 2 weeks post-treatment
Tissue appearance This parameter will be scored according to the consistency contour color match keloid formation degree and contiguity of the treated sites at T3 Consistency will be rated as firm 1p or spongy 0p contour as the presence 2p or absence 0p of knife-edged and scalloped GM color match as excellent 3p good 2p adequate 1p or unsatisfactory 0p keloid formation degree as absent 1p or present 0p and contiguity as the presence 1p or absence 0p of each perceptible incision mark Time Frame 6 and 12 months post-treatment
Aesthetic evaluation Aesthetics will be evaluated according to the five variables of root coverage esthetic score RES GM position marginal tissue contour MTC soft tissue texture STT MGJ alignment and gingival color GC GM position was scored as 0 3 or 6 whereas each other variable was scored as 0 or 1 Time Frame 6 and 12 months post-treatment
Dentin hypersensitivity Hypersensitivity will be recorded using a visual analog scale VAS 0 no pain 10 extreme pain after 3-s air blast applied to the cervical portions of the included sites from a triple syringe Time Frame Baseline 6 and 12 months post-treatment
Eligibility criteria Minimum Age 18 Years Maximum Age 60 Years Sex All Gender Based No Accepts Healthy Volunteers Yes
Inclusion Criteria
Participants aged 18 to 60 years Individuals with the gingival recession of Miller Class I II or III in at least one tooth in the anterior mandibular or maxillary region
Participants must have at least 1 mm of keratinized tissue width around the affected toothtooth and be in good general health
Ability to provide informed consent for participation in the study
Exclusion Criteria
Individuals with uncontrolled systemic diseases that could impact periodontal healing eg diabetes mellitus cardiovascular diseases
Current smokers or those who have quit smoking less than 6 months before the study
Women who are pregnant or breastfeeding Participants who have received periodontal or gingival recession treatment in the study area within the last year
Presence of acute periodontal or dental infections requiring immediate treatment or extensive caries affecting the study teeth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None