RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION
BY
DR.R.DIVAKARAN
1ST YEAR MDS
DEPARTMENT OF PERIODONTICS
2012
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL
BANGALORE- 562157
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
Proforma for registration of subjects for dissertation
1. Name of the candidate and address: / DR.R.DIVAKARANPost Graduate Student,
Department Of Periodontics, Krishnadevaraya College Of Dental Sciences,Krishnadevarayanagar,Hunasamaranahalli,
Bengaluru – 562157
2. Name Of The Institution: / Krishnadevaraya College Of Dental Sciences
3. Course of the study and subject: / Master of Dental Surgery
Periodontics
4. Date of admission of the course / 30thMay 2012
5. Title of the topic / LASER DE-EPITHELIALIZATION FOR EPITHELIAL EXCLUSION IN ROOT COVERAGE PROCEDURE:A CLINICAL STUDY
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR STUDY:
Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cemento enamel junction. Gingival recession may present without any symptoms, but sometimes it can give rise to pain from exposed dentin, sensitivity, root caries and esthetic concerns. Complete coverage of the recession defect and an optimal integration of the covering tissues with the adjacent soft tissues is an essential component of periodontal therapy.
Different treatment modalities have been employed to attain root coverage in gingival recessions. Among all the treatment modalities employed, coronally advanced flap with subepithelial connective tissue graft (CAF+SCTG) technique has maximum efficiency with 91.2% coverage1.In the CAF+SCTG technique, the soft tissue utilized to cover the root exposure is similar to that originally present at the buccal aspect of the tooth and thus the esthetic result is more satisfactory.
The tissue healing following periodontal surgery may be accompanied by apical migration of epithelial cells, preventing the regeneration.Successful treatment to obtain new attachment in gingival recession continues to represent serious challenges for predictable results. Epithelial proliferation apically along the healing root surface has shown to interfere with the establishment of a new connective tissue attachment and the ability to retard epithelial down-growth will be a significant variable in the surgical management of gingival recessions.
Many attempts to prevent epithelial migration have been done while attempting soft tissue coverage.The results from various human studies and clinical trials have proved the efficacy of guided tissue regeneration (GTR) in root coverage2. The concept behind GTR is the usage of barriers to exclude epithelial cells from migrating into the wound, in turn allowing the cells capable of regeneration to stimulate healing. LASER has also been significant in removing pocket epithelium and retarding epithelial migration into the pocket3. LASER can be considered as an effective alternative to GTR membrane2.
LASER finds a wide range of application in different areas of medicine, since its introduction in the year 1960 and 1964 for the first time in dentistry.Diode LASER emits a continuous beam with a 810, 940, 980, 1064 nm wavelength. LASER destroys tissue by thermal damage, rapidly heating and vaporizing intracellular water with minimal lateral energy spread. LASER has been used in the treatment of periodontal disease because of the antibacterial effects without inducing dramatic changes in the underlying tissues.
LASER de epithelialization of the pocket epithelium is a rather predictable method of epithelial exclusion as it creates a unique wound by instantaneous vaporization of the intracellular fluid and resultant disintegration of cell structure2.
The LASER wound causes a delay in re epithelialization because LASER wound margins show thermal necrosis and formation of a firm eschar that impedes epithelial migration, decreased wound contraction leaves a greater surface area remaining to be epithelialized and reduced inflammation also helps the cause2.
LASER de epithelialization when compared with GTR on epithelial exclusion histologically showed a new attachment formation in animals2. Open flap debridement with and without the use of LASER de epithelialization of the pocket epithelium inhuman interproximal intrabony defects showed periodontal regeneration for LASER de epithelialization2. Osteogenic activity appeared to be present at the crest and periodontal ligament side at the site treated with LASER de epithelialization2. LASER treated sites had significantly better gain in clinical attachment than the control sites2.Laser assisted new attachment procedure (LANAP) also provides evidence of new attachment with new cementum formation4.The results from human studies and case reports combined with the animal studies indicate the benefits of LASER de epithelialization technique. LASER de epithelialization has not been tried in root coverage procedures to exclude epithelial cells.
Considering the positive role LASER de epithelialization can play in epithelial exclusion, a similar approach is planned to de epithelialize the inner surface of flap by LASER to retard epithelial migration during the root coverage procedure utilising CAF + SCTG.
The purpose of the study is to compare the efficacy of LASER de epithelialization for epithelial retardation and its impact on the outcome of CAF+SCTG in the management of gingival recession.
6.2 REVIEW OF LITERATURE:
Centty et al. (1997)3 conducted a study to infer the efficiency of carbon dioxide LASER in epithelial elimination. The results showed that CO2 LASER eliminates significantly more epithelium than conventional periodontal surgery.
Salaria et al. (2010)8 presented a case report for the treatment of periodontitis with a new technique, LASER assisted modified widman flap (LAMWF). The LAMWF proved satisfactory results without complications.
Sanctis et al. (2011)1conducted a study to determine the use of connective tissue graft (CTG) in root coverage. The results proved CAF in association with CTG is a valid approach in the treatment of recession defects.
Ozturan et al. (2011)5conducted a study to assess the efficacy of low level LASER therapy(LLLT) with coronally advanced flap(CAF) for root coverage. The results of the study indicated that LLLT may improve the predictability of CAF in root coverage.
Crespi et al. (2011)11 conducted a study to examine the removal of the epithelium in the periodontal pocket with a diode LASER. The results proved the efficiency of epithelial elimination by diode LASER than conventional methods.
Nevins et al. (2012)4designed an investigation to evaluate the healing response to the LASER-assisted new attachment procedure. The results provided evidence of periodontal regeneration with new attachment and new cementum formation.
Moliner et al. (2012)9 designed a study to compare the tissue response and postoperative pain with the use of diode laser as an adjunct to modified widman flap(MWF) to that of MWF alone. The results substantiated the benefits of diode laser with less edema and postoperative pain.
6.3 OBJECTIVES OF THE STUDY:
The primary objective of this clinical trial is to compare the efficacy of diode LASER de epithelialization of the inner surface of CAF with SCTG and CAF with SCTG alone in the management of gingival recession defects in maxillary anteriors.
The secondary objective of this clinical trial is to assess the efficiency of LASER de epithelialization+CAF+SCTG in root coverage and CAF+SCTG alone in root coverage.
7. MATERIALS AND METHODS:
7.1 Source of data:
Patients visiting the Department of Periodontics, Krishnadevaraya College of Dental Sciences and Hospital and satisfying the inclusion and exclusion criteria will be selected for the study.
7.2 Method of collection of data:
Sample size:
This prospective clinical study is a single blind split mouth design. 20 patients with at least two teeth having Miller Class I or Class II recession in the maxillary anteriors will be selected.
Inclusion criteria:
· Miller ClassI and II recession in maxillary anteriors.
· Patients with at least two similar recession defects in the contralateral sides of maxillary anteriors.
· Systemically healthy patients.
· Patients willing to participate in study.
· Age group of 20-55 years.
· Patients with esthetic concerns.
Exclusion criteria:
· Medically compromised patients.
· Pregnant and lactating woman.
· Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
· Patients with history of smoking.
· Teeth with hopeless prognosis.
SAMPLING TECHNIQUE:
Each subject will be treated with an initial phase of oral hygiene instructions, scaling and root planning.Two weeks after completion of initial phase of therapy, the below mentioned clinical parameters will be recorded using a standardized acrylic occlusal stent and UNC-15 probe.
1. Gingival recession depth (GRD)
2. Gingival recession width (GRW)
3. Probing Depth (PD)
4. Clinical attachmentlevel (CAL)
5. Keratinized Tissue Width
6. Photographic evaluation using image analysis software (IMAJE J)
7. Subjective esthetic assessment using Visual Analog Scale(VAS)
8. Plaque Index (Sillness and Loe, 1964)
9. Gingival Index (Loe and Sillness, 1963)
10. Gingival Bleeding Index (Ainamo and Bay, 1975)
Patients satisfying the selection criteria with Class I and Class II gingival recession in maxillary anteriors will be enrolled for the study. The patients will be informed about the surgical procedure and materials used for the study and an informed consent will be obtained from the patients.
In the selected cases, randomly one of the defects will be treated with subepithelial connective tissue graft and coronally advanced flap whereas the contralateral side will be treated with LASER de epithelialization of the inner surface of the flap along with connective tissue graft and coronally advanced flap. All patients will receive oral hygiene instructions and scaling and root planning at least two weeks before CAF+SCTG procedure. Both test and control sites will undergo an identical CAF+SCTG procedure for root coverage.
SURGICAL PROCEDURE:
Before surgery, the sites will be allocated into test and control randomly. The surgical procedures used will be the same for both groups, except that one group will receive the SCTG and CAF (control group),while the other will receive laser deepithelialization of the inner surface of the CAF (test group) and SCTG. Under local anesthesia, an intrasulcular and two horizontal incisions will be made, starting at the CEJ of the tooth with the recession and extending to the CEJs of the adjacent teeth. Two oblique releasing incisions will be made beyond the mucogingival junction. The papillae adjacent to the treated tooth were deepithelialized to create a bleeding surface for a recipient bed, for the SCTG will be placed.
The surgical papillae will be dissected, split thickness, upto the probeable sulcular area, keeping the blade almost parallel to the root. The soft tissue apical to the root exposure will be elevated to full thickness by inserting a periosteal elevator into the sulcus and proceeding in the apical direction to expose 3-4mm of bone apical to the bone dehiscence. A gentle root debridement will be performed with sharp curettes on the exposed root surfaces. The most apical portion of the flap will be split thickness to allow coronal repositioning of the flap without tension5.
The test site will receive an application of diode laser with a wavelength of 820nm and a power of 1 watt in a continuous mode. LASER irradiation will be performed from the coronal to the apical aspect in parallel paths on the inner surface of the flap. The LASER beam will be moved laterally and apically to remove the sulcular epithelium. The LASER emission will be interrupted for 30 seconds after the irradiation exceeds 10 seconds in time. The resultant char layer will be removed totally with a moist gauze piece before replacing the flaps4.
The laser beam will be aimed at a 45º angle without contacting the root surface or alveolar bone. In the control sites, laser application will be simulated, without pushing the start button.
The donor site consisting of 2mm thick palatal connective tissue graft will be harvested from the premolar to the first molar areausing the ‘trap door’ technique6. The connective tissue graft will be secured in position with 4-0 absorbable sutures in both test and control sites. To permit the coronal advancement of the flap all muscle insertion present in the thickness of the flap will be eliminated. Coronal mobilization of the flap will be considered adequate when the marginal portion of the flap will be able to passively reach a level coronal to the CEJ of the teeth with recession defect. The flap should be stable in the final coronal position even without sutures. After the LASER de-epithelialization simulation the flaps will be repositioned coronally and stabilized with 4-0 interrupted sutures on both test and control sites5.
Postoperative care consisting of 0.2% chlorhexidine mouth rinse 3 times daily for 4 weeks will be advised to the patients. 100mg doxycycline twice daily will be given for 7 days and non-steroidal anti- inflammatory drugs for pain control will be given.
Patients will be recalled for reinforcement of oral hygiene procedures and clinical parameters will be recorded at 6 weeks, 3 months and 6 months after surgical reconstruction
STATISTICAL ANALYSIS:
The mean values will be compared between the test and control group using Mann-Whitney U test. Mean differences at different time intervals from the baseline value will be tested using Mann-Whitney U test separately for control and test group. A ‘p’ value of < 0.05 will be considered statistically significant.
7.3 Does the study require any investigation or intervention to be done on humans or animals?
Yes. The study requires a surgical approach where in a coronally advanced flap and a connective tissue graft with and without laser de epithelialization will be performed. The connective tissue graft harvested from the same person will be employed for the surgery.
7.4 Has the ethical clearance been obtained from your institution in the case above?
Yes. A copy of the same has been enclosed.
8. List of references:
1)Sanctis MD, Baldini N, Goracci C, Zuchhelli G.Coronally advanced flap associated with a
connectivetissue graft for the treatment of multiple recession defects in mandibular
posteriorteeth. Int J Periodontics Restorative Dent 2011;31:623-630.
2) Rossman JA, Israel M. Laser de-epithelialization for enhanced guided tissue
regeneration. A paradigm shift? Dent Clin. North Am 2000;44:793-809.
3) Centty IG, Blank LW, Levy BA, Romberg E, Barnes DM. Carbon dioxide laser for
de-epithelialization of periodontal flaps.J Periodontol 1997;68:763-769.
4) Nevins ML, Camelo M,Schupbach P, Kim SW, Kim DM, Nevins M. Human clinical and
histologic evaluation of laserassisted new attachment procedure. Int J Periodontics
Restorative Dent 2012;32:497-507.