Comparison of single flap approach to double flap approach for effective management of intraosseous defects in chronic periodontitis –A randomised controlled trial

Conventional surgical approach ie, double papilla approach for management of intraosseous defects includes raising of flaps on both buccal and lingual/palatal side after splitting the papilla with sulcular incision. This may cause unwanted interproximal bone exposure in cases of lesions confined to either buccal/lingual aspect which can eventually leads to impairment of interdental papilla and bone loss. To overcome this papilla preservation techniques were introduced.1 Narrow intrabony defects resulted in complete clinical repair even without regenerative therapy.Clinical outcomes of open flap debridement was as effective as open flap debridement and grafts in some studies of intrabony defect management.A novel, simplified, minimally-invasive surgical approach to access intraosseous periodontal defects with limited mucoperiosteal flap elevation is Single-flap approach(SFA) which allows access from either buccal or lingual aspect depending on  extension of the lesion leaving interproximal supracrestal gingival tissues intact. Radiographic density was not assessed in the study by Trombelli et al which will be assessed in this study as secondary outcome.Patients fulfilling inclusion criteria are subjected to full mouth scaling and root planning. Reevaluated at 6th week and clinical parameters recorded at that time as baseline records.Trained examiner other than the principal investigator assesses the clinical parameters. The examiner will be masked to treatment allocations for the entire duration of the study. All subjects shall be required to answer a detailed questionnaire including demographic information (name, Age, sex, Address), medical and dental history. Clinical parameters, recorded by a single, trained examiner other than the investigator at six aspects per tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual are gain in clinical attachment level (gCAL), probing depth reduction(PDR), and gingival recession (GRR) reduction using UNC-15 probe.Surgical Protocol: In SFA group: Buccal envelope flap without vertical releasing incisions with papilla preservation is done. In DFA group: Envelope flap without vertical releasing incisions is performed at both buccal and oral aspects splitting the papilla. In both groups, periosteal elevator is used to elevate the flaps and defect debrided with hand instruments. Flap closure is done, sutures are placed and surgical site is covered with periodontal dressing for one week. Patients are informed to report if any untoward complications develop immediately. Post surgical evaluation is done at 3 months and 6 months.

RESULTS:

Therewere no statistically significant difference in clinical and radiographicparameters between two groups tested at baseline (P value > 0.05). Henceboth groups were comparable at baseline. In SFA group, on comparingpre-surgical and postsurgical PPD and CAL at 3 months and 6 months, there wasstatistically significant mean PPD reduction and CAL gain (P value <0.05).Themean reduction in probing pocket depth at 3 months was 3.091 ± 0.735mm and at 6months was 3.636 ± 0.595mm (P value <0.001). The mean gain in clinicalattachment level was 3.136 ± 0 .839mm at 3 months and 3.727 ± 0.876mmat 6months(P value <0.001).The mean reduction in gingival recession in 3 monthsand from baseline to 6 months was 0.0 ± 0.447 which was not statisticallysignificant (P value = 1.00). In DFA group, on comparing pre-surgical andpostsurgical PPD and CAL at 3 months and 6 months, there was statisticallysignificant mean PPD reduction and CAL gain (P value <0.05). The meanreduction in probing pocket depth at 3 months was 3.182 ± .603mm and at 6monthswas 3.545 ± 0.522mm (P value <0.001). The mean gain in clinical attachmentlevel was 2.909 ± 0.831mm at 3 months and 3.273 ± 0.905mm at 6 months(P value<0.001).The mean increase in gingival recession in 3 months and frombaseline to 6 months was 0.273 ± 0.647mm which shows no statisticallysignificant difference. (P value = 0.192). In SFA group radiographic densityshowed a statistically significant difference at 6 months (P value <0.05)while comparing pre-surgical and post-surgical densitometric analysis. The meanchange in radiographic density was 15.333 ± 16.299 in 6 months. In DFA group radiographic density showed a statisticallysignificant difference at 6 months (P value <0.05) while comparingpre-surgical and post-surgical densitometric analysis. The mean change inradiographic density was 9.303 ± 20.602 in 6 months. On comparing change inprobing pocket depth in first 3 months between two groups, DFA showed a higherreduction in probing pocket depth by 0.0901mm (P value = .755) and higher post- surgical gingival recession of 0.273 in DFA group. (P value = .264). Clinicalattachment gain was higher in SFA by 0.227mm. But these changes were notstatistically significant (P value >0.05). On comparing change in clinicalparameters 6 months post surgically between two groups, SFA showed a slighthigher reduction in probing pocket depth by 0.091mm and slight higher clinicalattachment gain of 0.455mm. DFA showed slight higher post - surgical gingivalrecession of 0.273mm. These changes were not statistically significant (P value> 0.05). The change in radiographic density when compared between groups wasalso insignificant (P value > 0.05).