Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02393053
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2015-03-06
Brief Title:
Non-Pedicled Buccal Fat Pad Graft in the Treatment of Gingival Recessions
Sponsor:
Universidade Positivo
Organization:
Universidade Positivo
Study Overview
Official Title:
Innovation Technique With Non-pedicled Buccal Fat Pad Graft in the Treatment of Gingival Recessions a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Background This randomized controlled clinical study of split-mouth aimed to compare non-pedicled buccal fat pad graft BFPG with subepithelial connective tissue graft SCTG in the treatment of Miller Class I or II gingival recessions
Methods Twelve patients with Miller Class I or II 2 mm bilateral recessions in maxillary premolars or canines were selected The recessions were randomly assigned to receive SCTG Control Group or BFPG Test Group The clinical parameters of Gingival Index GI Plaque Index PI Probing Depth PD Gingival Recession GR Clinical Attachment Level CAL Width of Keratinized Tissue WKT Thickness of Keratinized Tissue TKT and Gingival Margin to the Acrylic Guide GM-AG were evaluated at baseline and in the postoperative periods of 1 3 and 6 months The percentage of root coverage was also evaluated Data were submitted to repeated measures ANOVA Bonferroni method and t-test p005
Methods Twelve patients with Miller Class I or II 2 mm bilateral recessions in maxillary premolars or canines were selected The recessions were randomly assigned to receive SCTG Control Group or BFPG Test Group The clinical parameters of Gingival Index GI Plaque Index PI Probing Depth PD Gingival Recession GR Clinical Attachment Level CAL Width of Keratinized Tissue WKT Thickness of Keratinized Tissue TKT and Gingival Margin to the Acrylic Guide GM-AG were evaluated at baseline and in the postoperative periods of 1 3 and 6 months The percentage of root coverage was also evaluated Data were submitted to repeated measures ANOVA Bonferroni method and t-test p005
Detailed Description:
MATERIALS AND METHODS
Study population This paper aims to report a randomized controlled clinical study of split-mouth 12 patients were selected 8 women and 4 men aged between 21 and 65 mean age 41 119 years They were informed about the risks and benefits of this clinical investigation as well as associated procedures and signed a free and informed consent form This study was approved by the Ethics and Research Committee of Positivo University 0832010
The inclusion criteria for the selection of patients were 1 patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines to 2 mm 2 patients who had recessions with some differences between the right and the left sides to 3 mm 3 non-smokers 4 non-pregnant patients 5 systemically healthy patients 6 periodontally healthy patients with no contraindications for periodontal surgery 7 patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue 8 teeth with probing depth PD 3 mm and without bleeding on probing BOP 9 teeth with no caries or restorations in the cervical region and 10 region that had not been undergone any periodontal surgery before
Initial therapy The patients underwent a basic periodontal treatment including scaling root planing tooth polishing and oral hygiene instructions as required Additionally all patients were included in a pre-treatment program in order to eliminate possible etiological factors related to gingival recession Patients were instructed to perform a non-traumatic brushing technique by using a toothbrush with soft bristles The surgical procedure was performed only in patients who had adequate plaque control
Clinical Parameters After 30 days of initial therapy the clinical parameters were recorded by a single calibrated operator with professional experience in periodontics at the beginning baseline and in the postoperative periods of 1 3 and 6 months respectively The periodontal probe used was North Carolina UNC-15 Hu-Friedy Chicago IL USA
At baseline an acrylic resin guide was made directly in the mouth of each patient and in each experimental tooth A reference point slot was created in the most central vestibular portion of the guide in order to obtain a fixed reproduction of the periodontal probe position so that the measures of the clinical parameters could be standardized
The clinical parameters evaluated were Gingival Index GI16 Plaque Index PI17 Probing Depth PD - measure from the gingival margin GM up to the bottom of the gingival sulcus Gingival Recession GR - measure from the Cemento-Enamel Junction CEJ up to the GM Clinical Attachment Level CAL - measure from the CEJ up to the bottom of the gingival sulcus Width of Keratinized Tissue WKT - measure from the Mucogingival Junction MGJ up to the GM Thickness of Keratinized Tissue TKT - measure performed with the aid of a North Carolina periodontal probe UNC-15 Hu-Friedy Chicago IL USA perpendicularly placed along the tooth axis in the most central portion of the keratinized tissue between the GM and the MGJ The probe was slightly pressured under local anesthetic towards the adjacent hard tissue Then the measure in millimeters was recorded and the last mean calculated referred to the Gingival Margin to the Acrylic Guide GM-AG - measure performed from the GM up to the most coronal point of the acrylic resin guide
Surgical Procedure All surgical procedures were performed by the same operator experienced and specialist in Periodontics The bilateral gingival recessions were randomly assigned by lot by a flip of coins for both the side that received the SCTG Control Group - C and the side that received the BFPG Test Group - T The same operator performed both surgeries on the same day
Before the surgical procedure extra intra-oral antisepsis was performed with 012 chlorhexidine digluconate The clinical parameters GI and PI were evaluated Then measures of the clinical parameters PD GR CAL WKT and GM-AG were performed with the aid of an acrylic guide
Preparation of the recipient site After local infiltration anesthetic mepivacaine HCL 2 epinephrine 1100000 at the bottom of the vestibule in the region of the upper canine or upper premolar teeth the measure TKT was performed Then an intrasulcular incision was made with a scalpel blade no 15c from the distal side of the upper canine tooth or the premolar tooth towards their mesial side with great care so that the interdental papillae could be preserved After that two divergent vertical releasing incisions were made towards the bottom of the vestibule A partial-thickness flap was raised releasing all muscle fibers so that the flap could be loose to be slid coronally The roots were gently debrided and flattened with Gracey curettes 5-6 Hu-Friedy - USA and the area was rinsed with sterile saline solution for the total removal of dentine debris Then with the aid of an acrylic guide the measure of the most coronal portion of the recipient site to the acrylic guide CPRS-AG was performed The flap had to be raised so that the measure of the most coronal portion of bone tissue over the root to the acrylic guide could be made
The standard surgical procedure was to start on the patients right side regardless of the group that would undergo surgery Group C or Group T The preparation of the recipient site was conducted the same way for both groups
Preparation of the donor site In order to obtain connective tissue graft the patient was given infiltration anesthetic into the hard palate on the same side of the recipient site randomly chosen by lot to receive the SCTG The removal of the connective tissue was performed followed by an L-shaped incision
Once the graft was harvested it was immediately positioned onto the recipient site at the level of the CEJ and fixed through simple sutures in the mesial and distal sides with a V-shaped compressive suture Fig 1A from the periosteum to the palatine region of the tooth with absorbable suture thread After the graft was sutured with the aid of an acrylic guide the following measures were performed 1 the measure of the most coronal portion of the graft to the acrylic guide CPG-AG and 2 the apico-coronal height of the graft ACHG The height of the graft ranged from 65 to 89 mm for all 12 patients
The flap was positioned coronally in order to cover the connective tissue graft as a whole Suspensory and simple sutures were made in the releasing incisions with silk thread Fig 1B After the sutures were finished the measure of the most coronal position of the flap to the acrylic guide CPF-AG was performed
In order to harvest BFPG Bichats Ball a terminal infiltration anesthetic was injected into the region of the upper first and second molars on the same side of the recipient site that would receive BFPG A horizontal incision measuring 15 cm was made with a blade no15 at the bottom of the vestibule in the region of the teeth 16 and 17 or 26 and 27 depending on which side the surgery would be performed in accordance with the random choice established by lot for the Test Group A curved hemostat was used to divulse the muscles in the spot and to expose the adipose tissue The Bichats Ball was exposed as soon as the muscles were divulsed in the spot Fig 2A Then a small portion of adipose tissue 15 cm x 15 cm was removed with the aid of Goldman Fox scissors After this procedure the patients cheek was compressed in order for the wound edges to close joining the tissue The donor site was immediately sutured with silk thread 40 Ethicon Johnson Johnson AG Brazil through simple stitches
The BFPG was placed onto the recipient site at the level of the CEJ and fixed through X-shaped sutures over the graft Fig 2B with absorbable suture thread Vicryl 5-0 The same trans-surgical measures that had been performed in the Control Group were also performed in the Test Group The height of the graft ranged from 770 to 103 mm for all 12 patients
The flap was positioned coronally in order to cover the BFPG as a whole Suspensory and simple sutures were made in the releasing incisions Fig 2C After the sutures were finished the measure of the most coronal position of the flap to the acrylic guide CPF-AG was performed
Postoperative Protocol The patients were given postoperative instructions such as ice compress on the surgical site during the first 04 hours liquid andor soft diet for 3 days the teeth in the surgical region should not be brushed and the mouth should be rinsed with a mouthwash containing 012 chlorhexidine digluconate during 1 minute every 12 hours for 14 days
The postoperative medications prescribed were Amoxicillin 500 mg every 8 hours for 7 days or Clindamycin 300 mg every 8 hours for 7 days to patients allergic to penicillin and Ibuprofen arginine 600 mg every 12 hours for 5 days The sutures were removed 14 days after surgery After this period the patients were recommended to gently brush their teeth with a soft-bristle toothbrush
All patients were included in a monthly program of professional tooth cleaning and oral hygiene instructions starting on the 30th day until the 180th day after the surgical procedures
Statistical analysis Repeated Measures ANOVA associated with the Bonferroni method were used to detect inter- and intra-group differences for the clinical parameters PD GR CAL WKT TKT and GM-AG The t-test was used to detect inter-group differences versus time for the clinical parameters PD GR CAL WKT TKT and GM-AG For the parameters CPRS-AG CPG-AG ACHG and CPF-AG only the t-test was used The level of significance was 5 for all statistical comparisons All analyses were made with the aid of the software SPSS Statistics 18
Study population This paper aims to report a randomized controlled clinical study of split-mouth 12 patients were selected 8 women and 4 men aged between 21 and 65 mean age 41 119 years They were informed about the risks and benefits of this clinical investigation as well as associated procedures and signed a free and informed consent form This study was approved by the Ethics and Research Committee of Positivo University 0832010
The inclusion criteria for the selection of patients were 1 patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines to 2 mm 2 patients who had recessions with some differences between the right and the left sides to 3 mm 3 non-smokers 4 non-pregnant patients 5 systemically healthy patients 6 periodontally healthy patients with no contraindications for periodontal surgery 7 patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue 8 teeth with probing depth PD 3 mm and without bleeding on probing BOP 9 teeth with no caries or restorations in the cervical region and 10 region that had not been undergone any periodontal surgery before
Initial therapy The patients underwent a basic periodontal treatment including scaling root planing tooth polishing and oral hygiene instructions as required Additionally all patients were included in a pre-treatment program in order to eliminate possible etiological factors related to gingival recession Patients were instructed to perform a non-traumatic brushing technique by using a toothbrush with soft bristles The surgical procedure was performed only in patients who had adequate plaque control
Clinical Parameters After 30 days of initial therapy the clinical parameters were recorded by a single calibrated operator with professional experience in periodontics at the beginning baseline and in the postoperative periods of 1 3 and 6 months respectively The periodontal probe used was North Carolina UNC-15 Hu-Friedy Chicago IL USA
At baseline an acrylic resin guide was made directly in the mouth of each patient and in each experimental tooth A reference point slot was created in the most central vestibular portion of the guide in order to obtain a fixed reproduction of the periodontal probe position so that the measures of the clinical parameters could be standardized
The clinical parameters evaluated were Gingival Index GI16 Plaque Index PI17 Probing Depth PD - measure from the gingival margin GM up to the bottom of the gingival sulcus Gingival Recession GR - measure from the Cemento-Enamel Junction CEJ up to the GM Clinical Attachment Level CAL - measure from the CEJ up to the bottom of the gingival sulcus Width of Keratinized Tissue WKT - measure from the Mucogingival Junction MGJ up to the GM Thickness of Keratinized Tissue TKT - measure performed with the aid of a North Carolina periodontal probe UNC-15 Hu-Friedy Chicago IL USA perpendicularly placed along the tooth axis in the most central portion of the keratinized tissue between the GM and the MGJ The probe was slightly pressured under local anesthetic towards the adjacent hard tissue Then the measure in millimeters was recorded and the last mean calculated referred to the Gingival Margin to the Acrylic Guide GM-AG - measure performed from the GM up to the most coronal point of the acrylic resin guide
Surgical Procedure All surgical procedures were performed by the same operator experienced and specialist in Periodontics The bilateral gingival recessions were randomly assigned by lot by a flip of coins for both the side that received the SCTG Control Group - C and the side that received the BFPG Test Group - T The same operator performed both surgeries on the same day
Before the surgical procedure extra intra-oral antisepsis was performed with 012 chlorhexidine digluconate The clinical parameters GI and PI were evaluated Then measures of the clinical parameters PD GR CAL WKT and GM-AG were performed with the aid of an acrylic guide
Preparation of the recipient site After local infiltration anesthetic mepivacaine HCL 2 epinephrine 1100000 at the bottom of the vestibule in the region of the upper canine or upper premolar teeth the measure TKT was performed Then an intrasulcular incision was made with a scalpel blade no 15c from the distal side of the upper canine tooth or the premolar tooth towards their mesial side with great care so that the interdental papillae could be preserved After that two divergent vertical releasing incisions were made towards the bottom of the vestibule A partial-thickness flap was raised releasing all muscle fibers so that the flap could be loose to be slid coronally The roots were gently debrided and flattened with Gracey curettes 5-6 Hu-Friedy - USA and the area was rinsed with sterile saline solution for the total removal of dentine debris Then with the aid of an acrylic guide the measure of the most coronal portion of the recipient site to the acrylic guide CPRS-AG was performed The flap had to be raised so that the measure of the most coronal portion of bone tissue over the root to the acrylic guide could be made
The standard surgical procedure was to start on the patients right side regardless of the group that would undergo surgery Group C or Group T The preparation of the recipient site was conducted the same way for both groups
Preparation of the donor site In order to obtain connective tissue graft the patient was given infiltration anesthetic into the hard palate on the same side of the recipient site randomly chosen by lot to receive the SCTG The removal of the connective tissue was performed followed by an L-shaped incision
Once the graft was harvested it was immediately positioned onto the recipient site at the level of the CEJ and fixed through simple sutures in the mesial and distal sides with a V-shaped compressive suture Fig 1A from the periosteum to the palatine region of the tooth with absorbable suture thread After the graft was sutured with the aid of an acrylic guide the following measures were performed 1 the measure of the most coronal portion of the graft to the acrylic guide CPG-AG and 2 the apico-coronal height of the graft ACHG The height of the graft ranged from 65 to 89 mm for all 12 patients
The flap was positioned coronally in order to cover the connective tissue graft as a whole Suspensory and simple sutures were made in the releasing incisions with silk thread Fig 1B After the sutures were finished the measure of the most coronal position of the flap to the acrylic guide CPF-AG was performed
In order to harvest BFPG Bichats Ball a terminal infiltration anesthetic was injected into the region of the upper first and second molars on the same side of the recipient site that would receive BFPG A horizontal incision measuring 15 cm was made with a blade no15 at the bottom of the vestibule in the region of the teeth 16 and 17 or 26 and 27 depending on which side the surgery would be performed in accordance with the random choice established by lot for the Test Group A curved hemostat was used to divulse the muscles in the spot and to expose the adipose tissue The Bichats Ball was exposed as soon as the muscles were divulsed in the spot Fig 2A Then a small portion of adipose tissue 15 cm x 15 cm was removed with the aid of Goldman Fox scissors After this procedure the patients cheek was compressed in order for the wound edges to close joining the tissue The donor site was immediately sutured with silk thread 40 Ethicon Johnson Johnson AG Brazil through simple stitches
The BFPG was placed onto the recipient site at the level of the CEJ and fixed through X-shaped sutures over the graft Fig 2B with absorbable suture thread Vicryl 5-0 The same trans-surgical measures that had been performed in the Control Group were also performed in the Test Group The height of the graft ranged from 770 to 103 mm for all 12 patients
The flap was positioned coronally in order to cover the BFPG as a whole Suspensory and simple sutures were made in the releasing incisions Fig 2C After the sutures were finished the measure of the most coronal position of the flap to the acrylic guide CPF-AG was performed
Postoperative Protocol The patients were given postoperative instructions such as ice compress on the surgical site during the first 04 hours liquid andor soft diet for 3 days the teeth in the surgical region should not be brushed and the mouth should be rinsed with a mouthwash containing 012 chlorhexidine digluconate during 1 minute every 12 hours for 14 days
The postoperative medications prescribed were Amoxicillin 500 mg every 8 hours for 7 days or Clindamycin 300 mg every 8 hours for 7 days to patients allergic to penicillin and Ibuprofen arginine 600 mg every 12 hours for 5 days The sutures were removed 14 days after surgery After this period the patients were recommended to gently brush their teeth with a soft-bristle toothbrush
All patients were included in a monthly program of professional tooth cleaning and oral hygiene instructions starting on the 30th day until the 180th day after the surgical procedures
Statistical analysis Repeated Measures ANOVA associated with the Bonferroni method were used to detect inter- and intra-group differences for the clinical parameters PD GR CAL WKT TKT and GM-AG The t-test was used to detect inter-group differences versus time for the clinical parameters PD GR CAL WKT TKT and GM-AG For the parameters CPRS-AG CPG-AG ACHG and CPF-AG only the t-test was used The level of significance was 5 for all statistical comparisons All analyses were made with the aid of the software SPSS Statistics 18
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None